Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541574
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair FIXER Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair FIXER Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIXER
Brief Summary:
I Title Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair FIXER Trial
Todays Date September 18 2023 II Principal Investigator
Principal Investigator Christopher D Riemann MD Cincinnati Eye Institute
Email criemanncvphealthcom Phone 513-708-1979
V Research Summary
Purpose
To evaluate methotrexate for the prevention of PVR after primary rhegmatogenous retinal detachment repair
Methods
Inclusion Criteria
Any adult patient age 18 years-old undergoing primary rhegmatogenous retinal detachment surgery with pars plana vitrectomy at the Cincinnati Eye Institute in Blue Ash Ohio who is able to give informed consent
Exclusion Criteria
Age amplt18 years old
Pregnant patients or patients of child bearing potential unwilling to utilize long term contraception for the 12-week period spanning vitrectomy surgery for retinal detachment repair up until the 3 month postoperative visit
History of endophthalmitis ruptured globe or significant trauma in the affected eye
Chronic retinal detachment symptoms greater than or equal to six weeks
Any previous previous retinal detachment repair with pars plana vitrectomy or scleral buckling surgery Patients having undergone previous pneumatic retinopexy will not be excluded
Presence of Grade C PVR full thickness retinal folds or subretinal bands
Patients with contraindications to methotrexate including breastfeeding pregnancy attempting to conceive a child or any known hypersensitivity or intolerance to methotrexate
Patients with diminished mental capacity precluding their ability to give informed consent
Study Design and Randomization This prospective double masked trial will randomize patients into four groups in a 1111 fashion All attending surgeons and patients will be masked to group randomization Randomization into four groups will occur on the day of surgery by the Cincinnati Eye Institutes pharmacist Deepali Chachare Group A will consist of 150 patients receiving intraoperative infusion with balanced salt solution containing methotrexate 40mg500mL BSS and methotrexate intravitreal injections 400mcg005mL at postoperative weeks 1 3 6 and 10 Group B will consist of 150 patients receiving intraoperative balanced salt solution infusion containing methotrexate and sham intravitreal injections at postoperative weeks 1 3 6 and 10 Group C will consist of 150 patients receiving a balanced salt solution infusion without methotrexate and methotrexate injections at postoperative weeks 1 3 6 and 10 Group D will consist of 150 patients receiving intraoperative balanced salt solution infusion without methotrexate and sham intravitreal injections at postoperative weeks 1 3 6 and 10
Todays Date September 18 2023 II Principal Investigator
Principal Investigator Christopher D Riemann MD Cincinnati Eye Institute
Email criemanncvphealthcom Phone 513-708-1979
V Research Summary
Purpose
To evaluate methotrexate for the prevention of PVR after primary rhegmatogenous retinal detachment repair
Methods
Inclusion Criteria
Any adult patient age 18 years-old undergoing primary rhegmatogenous retinal detachment surgery with pars plana vitrectomy at the Cincinnati Eye Institute in Blue Ash Ohio who is able to give informed consent
Exclusion Criteria
Age amplt18 years old
Pregnant patients or patients of child bearing potential unwilling to utilize long term contraception for the 12-week period spanning vitrectomy surgery for retinal detachment repair up until the 3 month postoperative visit
History of endophthalmitis ruptured globe or significant trauma in the affected eye
Chronic retinal detachment symptoms greater than or equal to six weeks
Any previous previous retinal detachment repair with pars plana vitrectomy or scleral buckling surgery Patients having undergone previous pneumatic retinopexy will not be excluded
Presence of Grade C PVR full thickness retinal folds or subretinal bands
Patients with contraindications to methotrexate including breastfeeding pregnancy attempting to conceive a child or any known hypersensitivity or intolerance to methotrexate
Patients with diminished mental capacity precluding their ability to give informed consent
Study Design and Randomization This prospective double masked trial will randomize patients into four groups in a 1111 fashion All attending surgeons and patients will be masked to group randomization Randomization into four groups will occur on the day of surgery by the Cincinnati Eye Institutes pharmacist Deepali Chachare Group A will consist of 150 patients receiving intraoperative infusion with balanced salt solution containing methotrexate 40mg500mL BSS and methotrexate intravitreal injections 400mcg005mL at postoperative weeks 1 3 6 and 10 Group B will consist of 150 patients receiving intraoperative balanced salt solution infusion containing methotrexate and sham intravitreal injections at postoperative weeks 1 3 6 and 10 Group C will consist of 150 patients receiving a balanced salt solution infusion without methotrexate and methotrexate injections at postoperative weeks 1 3 6 and 10 Group D will consist of 150 patients receiving intraoperative balanced salt solution infusion without methotrexate and sham intravitreal injections at postoperative weeks 1 3 6 and 10
Detailed Description:
I Title Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair FIXER Trial
IV General Study Information ing on the surgeon and technique successful retinal reattachment rates range from 70-80 for PR and even higher with SB andor PPV10 Proliferative vitreoretinopathy PVR the formation of proliferative fibrocellular membranous tissue overlying the retina can cause contracture and subsequent recurrent tractional retinal detachment PVR is the leading cause of failure following RRD repair complicating 10 of routine RRD procedures and a higher fraction of RRD in the setting of higher risk scenarios and occurs approximately 4000 times per year in the US1112 Risk factors for PVR formation including duration of RRD uveitis myopia -500 lens status number of retinal breaks size of breaks duration of photopsiasfloatersshadows presence of macula detachment giant retinal tears vitreous hemorrhage and history of trauma These risk factors will all be collected Intraoperative data collected will include vitrectomy gauge use of a drainage retinotomy use of scleral buckle type of retinal tamponade air SF6 C3F8 or silicone oil fellow surgeon involvement duration of surgery development of choroidal detachment amount of laser spots amount of laser energy number of retinal breaks total clock hours of retinal breaks and surgical complications Surgically removing PVR to reattach the retina can be exceedingly challenging resulting in poor visual outcomes with reattachment rates ranging from 60-8011 Furthermore even with successful anatomic reattachment only 40-80 of patients recover ambulatory vision or better11 The most commonly cited classification system to grade PVR is the updated Retina Society Classification in 2016 This system describes PVR into grades A-C with increasing severity Grade A PVR is described as haziness in the vitreous haze or clumps of pigment representing the migration of RPE cells into the vitreous Grade B is described wrinkling of the retinal surface rolled edges of a retinal tear or retinal stiffness Grade C-Posterior is described as a full-thickness retinal folds or subretinal strands posterior to equator Grade C-Anterior is described as full-thickness retinal folds or subretinal strands anterior to equator anterior displacement and condensed vitreous strands13
As of this writing there are no prospective human studies demonstrating that a prophylactic medication can successfully prevent PVR PVR prevention represents a significant unmet medical need Methotrexates proven antiproliferative and anti-inflammatory properties make it a promising candidate for prevention of PVR Methotrexate exerts several anti-inflammatory and antiproliferative biochemical mechanisms including competitive antagonism of dihydrofolate reductase inhibition of purine and pyrimidine synthesis transmethylation reactions and nitric oxide production14 Moreover methotrexate has long been used to treat intraocular lymphoma and refractory uveitis with an established intraocular dosing regimen and excellent intraocular safety profiles as described above
Based on these long established - now standard of care - protocols in the ocular oncology and uveitis literature a rational dosing strategy for our study of methotrexate for PBVR prevention was established as follows The standard intravitreal dose of methotrexate for primary intraocular lymphoma and refractory posterior uveitis is 400mcg into an approximately 5mL eye Dosing regimens for these two diseases are typically two injections per week for 1 month 1 injection per week for 2 months and 1 injection per month for 9 additional months Extensive off-label clinical experience by our group with methotrexate for PVR prevention in high-risk scenarios going back to 2006 has led our group to believe that this very aggressive dosing regimen is not needed for a substantial anti PVR effect Furthermore the well documented side effect of corneal toxicity is much less frequent at a less aggressive dosing regimen and to that end we have adapted the following dosing strategy During vitrectomy surgery for retinal detachment repair 40mg of methotrexate is placed into a 500mL bottle of BSS intraocular irrigation solution yielding and identical final intraocular concentration of methotrexate that is equal to a 400mcg injection into a 5 mL eyeball Methotrexate is a small and readily soluble molecule so an equilibrium of therapeutic tissue concentrations is achieved quickly Following the aqueous phase of retinal detachment surgery the methotrexate containing BSS infusion is turned off all intraocular BSS is removed and replaced with a vitreous fill of either air gas or silicon oil The resulting dramatically altered distribution volume of any water-soluble drug makes intraoperative injection dosing at the end of the surgical case very problematic The intraoperative infusion methodology eliminates these concerns and doses the eye at the time when surgical manipulation and injury which are felt to be causative factors in PVR formation occur We selected the intraoperative intraocular infusion strategy because of the direct and controlled ocular drug delivery the ease of this dosing strategy the simplicity of masking both the surgeon and patient with an opaquer plastic bag covering the infusion bottle and the elimination of systemic side effect concerns Our postoperative injection regimen of 400mcg intravitreal injections - one three six and ten weeks postoperatively - was developed to 1 provide greatest antiproliferative and anti-inflammatory effects closer to the period of surgical injury 2 maintain persistent effects through the typical PVR formation window of 4 - 8 weeks after surgery and 3 minimize the corneal toxicity of accumulating methotrexate exposure Our group has published and presented convincing evidence that both intraoperative infusion and postoperative injection dosing have clinical efficacy It remains to be elucidated whether the infusion approach the injection approach or a combination of both are needed for optimal effect This is the underlying rationale for the 1111 randomization strategy into four groups
Detailed Study Visit Description
The Study will consist of 11 visits spread out over about 12 months These are summarized in the table attached below In order
Visit Number -1 Preop screening 1 - 14 days prior to surgery This is the visit at which the patientamp39s retinal detachment will be diagnosed and the surgical plan for repair established
Snellen visual acuity and optional ETDRS visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded The patient will be screened for inclusion and exclusion criteria Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential The detained geometry of the retinal detachment and associated retinal pathologies will be recorded Recording of PVR risk factors Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy The patient will sign the clinic based informed consent to proceed with surgery
If the patient meets the inclusion criteria for the trial the patient will be invited to participate in the trial and be given the study informed consent document to review
The patient will be tentatively randomized into one of the 4 study groups to aid with preoperative work flow and possible methotrexate preparation requirements for surgery
Visit Number 0 Surgery
The ambulatory surgery center informed consent to treat will be signed Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential The study informed consent document is signed by the patient The patient will be definitively randomized into one of the 4 study groups Vitrectomy surgery for retinal detachment repair will be performed The detained geometry of the retinal detachment and associated retinal pathologies will be recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy
Visit Number 1 Postop Day 1
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects
Visit Number 2 Postop Week 1 3 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential Sham or real methotrexate injection according to patient study group randomization by unmasked investigator
Visit Number 3 Postop Week 3 3 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential Sham or real methotrexate injection according to patient study group randomization by unmasked investigator
Visit Number 4 Postop Week 6 7 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential Sham or real methotrexate injection according to patient study group randomization by unmasked investigator
Visit Number 5 Postop Week 10 7 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential Sham or real methotrexate injection according to patient study group randomization by unmasked investigator
Visit Number 6 Postop Month 4 14 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects
Visit Number 7 Postop Month 6 28 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects
Visit Number 8 Postop Month 9 28 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects
Visit Number 9 Postop Month 12 28 days
Snellen visual acuity will be obtained ETDRS visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects
VI Statistical Analysis All data will be tabulated on a secure Microsoft Excel document All information will be stored on a password protected Cincinnati Eye Institute computer on its secure HIPPA compliant network Only study investigators will have password access to this secure spreadsheet An Analysis of Variance ANOVA table will be generated for each variable to determine statistical significance p lt 005
Statistical power calculations show that an N of 215 patients in each group will allow for detection of a reduction in PVR rate from 10 to 5 and an N of 50 patients will allow for detection of a reduction in PVR rate from 10 to 1 so this study should be fully recruited in approximately 1 year given current patient volumes
IV General Study Information ing on the surgeon and technique successful retinal reattachment rates range from 70-80 for PR and even higher with SB andor PPV10 Proliferative vitreoretinopathy PVR the formation of proliferative fibrocellular membranous tissue overlying the retina can cause contracture and subsequent recurrent tractional retinal detachment PVR is the leading cause of failure following RRD repair complicating 10 of routine RRD procedures and a higher fraction of RRD in the setting of higher risk scenarios and occurs approximately 4000 times per year in the US1112 Risk factors for PVR formation including duration of RRD uveitis myopia -500 lens status number of retinal breaks size of breaks duration of photopsiasfloatersshadows presence of macula detachment giant retinal tears vitreous hemorrhage and history of trauma These risk factors will all be collected Intraoperative data collected will include vitrectomy gauge use of a drainage retinotomy use of scleral buckle type of retinal tamponade air SF6 C3F8 or silicone oil fellow surgeon involvement duration of surgery development of choroidal detachment amount of laser spots amount of laser energy number of retinal breaks total clock hours of retinal breaks and surgical complications Surgically removing PVR to reattach the retina can be exceedingly challenging resulting in poor visual outcomes with reattachment rates ranging from 60-8011 Furthermore even with successful anatomic reattachment only 40-80 of patients recover ambulatory vision or better11 The most commonly cited classification system to grade PVR is the updated Retina Society Classification in 2016 This system describes PVR into grades A-C with increasing severity Grade A PVR is described as haziness in the vitreous haze or clumps of pigment representing the migration of RPE cells into the vitreous Grade B is described wrinkling of the retinal surface rolled edges of a retinal tear or retinal stiffness Grade C-Posterior is described as a full-thickness retinal folds or subretinal strands posterior to equator Grade C-Anterior is described as full-thickness retinal folds or subretinal strands anterior to equator anterior displacement and condensed vitreous strands13
As of this writing there are no prospective human studies demonstrating that a prophylactic medication can successfully prevent PVR PVR prevention represents a significant unmet medical need Methotrexates proven antiproliferative and anti-inflammatory properties make it a promising candidate for prevention of PVR Methotrexate exerts several anti-inflammatory and antiproliferative biochemical mechanisms including competitive antagonism of dihydrofolate reductase inhibition of purine and pyrimidine synthesis transmethylation reactions and nitric oxide production14 Moreover methotrexate has long been used to treat intraocular lymphoma and refractory uveitis with an established intraocular dosing regimen and excellent intraocular safety profiles as described above
Based on these long established - now standard of care - protocols in the ocular oncology and uveitis literature a rational dosing strategy for our study of methotrexate for PBVR prevention was established as follows The standard intravitreal dose of methotrexate for primary intraocular lymphoma and refractory posterior uveitis is 400mcg into an approximately 5mL eye Dosing regimens for these two diseases are typically two injections per week for 1 month 1 injection per week for 2 months and 1 injection per month for 9 additional months Extensive off-label clinical experience by our group with methotrexate for PVR prevention in high-risk scenarios going back to 2006 has led our group to believe that this very aggressive dosing regimen is not needed for a substantial anti PVR effect Furthermore the well documented side effect of corneal toxicity is much less frequent at a less aggressive dosing regimen and to that end we have adapted the following dosing strategy During vitrectomy surgery for retinal detachment repair 40mg of methotrexate is placed into a 500mL bottle of BSS intraocular irrigation solution yielding and identical final intraocular concentration of methotrexate that is equal to a 400mcg injection into a 5 mL eyeball Methotrexate is a small and readily soluble molecule so an equilibrium of therapeutic tissue concentrations is achieved quickly Following the aqueous phase of retinal detachment surgery the methotrexate containing BSS infusion is turned off all intraocular BSS is removed and replaced with a vitreous fill of either air gas or silicon oil The resulting dramatically altered distribution volume of any water-soluble drug makes intraoperative injection dosing at the end of the surgical case very problematic The intraoperative infusion methodology eliminates these concerns and doses the eye at the time when surgical manipulation and injury which are felt to be causative factors in PVR formation occur We selected the intraoperative intraocular infusion strategy because of the direct and controlled ocular drug delivery the ease of this dosing strategy the simplicity of masking both the surgeon and patient with an opaquer plastic bag covering the infusion bottle and the elimination of systemic side effect concerns Our postoperative injection regimen of 400mcg intravitreal injections - one three six and ten weeks postoperatively - was developed to 1 provide greatest antiproliferative and anti-inflammatory effects closer to the period of surgical injury 2 maintain persistent effects through the typical PVR formation window of 4 - 8 weeks after surgery and 3 minimize the corneal toxicity of accumulating methotrexate exposure Our group has published and presented convincing evidence that both intraoperative infusion and postoperative injection dosing have clinical efficacy It remains to be elucidated whether the infusion approach the injection approach or a combination of both are needed for optimal effect This is the underlying rationale for the 1111 randomization strategy into four groups
Detailed Study Visit Description
The Study will consist of 11 visits spread out over about 12 months These are summarized in the table attached below In order
Visit Number -1 Preop screening 1 - 14 days prior to surgery This is the visit at which the patientamp39s retinal detachment will be diagnosed and the surgical plan for repair established
Snellen visual acuity and optional ETDRS visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded The patient will be screened for inclusion and exclusion criteria Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential The detained geometry of the retinal detachment and associated retinal pathologies will be recorded Recording of PVR risk factors Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy The patient will sign the clinic based informed consent to proceed with surgery
If the patient meets the inclusion criteria for the trial the patient will be invited to participate in the trial and be given the study informed consent document to review
The patient will be tentatively randomized into one of the 4 study groups to aid with preoperative work flow and possible methotrexate preparation requirements for surgery
Visit Number 0 Surgery
The ambulatory surgery center informed consent to treat will be signed Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential The study informed consent document is signed by the patient The patient will be definitively randomized into one of the 4 study groups Vitrectomy surgery for retinal detachment repair will be performed The detained geometry of the retinal detachment and associated retinal pathologies will be recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy
Visit Number 1 Postop Day 1
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects
Visit Number 2 Postop Week 1 3 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential Sham or real methotrexate injection according to patient study group randomization by unmasked investigator
Visit Number 3 Postop Week 3 3 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential Sham or real methotrexate injection according to patient study group randomization by unmasked investigator
Visit Number 4 Postop Week 6 7 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential Sham or real methotrexate injection according to patient study group randomization by unmasked investigator
Visit Number 5 Postop Week 10 7 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects Pregnancy screen and contraception discussion as appropriate for patients of child bearing potential Sham or real methotrexate injection according to patient study group randomization by unmasked investigator
Visit Number 6 Postop Month 4 14 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects
Visit Number 7 Postop Month 6 28 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects
Visit Number 8 Postop Month 9 28 days
Snellen visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects
Visit Number 9 Postop Month 12 28 days
Snellen visual acuity will be obtained ETDRS visual acuity will be obtained IOP will be determined Slit lamp exam and dilated fundus exam will be performed and recorded Recording of presence of PVR and or ERM Recording of presence of corneal epitheliopathy Recording of other ocular methotrexate side effects
VI Statistical Analysis All data will be tabulated on a secure Microsoft Excel document All information will be stored on a password protected Cincinnati Eye Institute computer on its secure HIPPA compliant network Only study investigators will have password access to this secure spreadsheet An Analysis of Variance ANOVA table will be generated for each variable to determine statistical significance p lt 005
Statistical power calculations show that an N of 215 patients in each group will allow for detection of a reduction in PVR rate from 10 to 5 and an N of 50 patients will allow for detection of a reduction in PVR rate from 10 to 1 so this study should be fully recruited in approximately 1 year given current patient volumes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None