Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02140164
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2014-05-14
Brief Title:
Study of Oral Minocycline in Treating Bilateral Cystoid Macular Edema Associated With Retinitis Pigmentosa
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study to Evaluate Oral Minocycline in the Treatment of Cystoid Macular Edema Associated With Retinitis Pigmentosa
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- Some people with retinitis pigmentosa RP have macular edema swelling in the central retina This can cause decreased central vision The cause of macular edema is unknown but may involve inflammation The drug minocycline might help prevent inflammation and therefore might help treat macular edema and improve central visual function
Objectives
- To see if minocycline helps people with RP and macular edema
Eligibility
- People 12 years and older with RP who have macular edema in at least on eye
Design
Participants will be screened with medical and eye disease history They will have an eye exam and blood tests One eye with macular edema will be the study eye If both eyes are affected one will be designated the study eye
Participants will visit the clinic at least 9 times over at least 14 months The first 3 study visits will be monthly then every 2 months
Participants will start taking minocycline after visit 3 They will take 1 pill twice daily for at least 1 year
Participants will keep a medicine diary and bring it to each visit with their pill bottle and unused pills
At each study visit participants will have some or all of the following tests
eye and thyroid exams
blood and pregnancy tests
microperimetry participants will press a button when they see a light on a computer screen
visual field measurement participants will look at spots on a white screen to test side vision
electroretinogram A person will be dark adapted by sitting in the dark for 30 minutes After the placement of numbing eye drops special contact lenses will be placed The participant will watch flashing lights and recordings will be made
- Some people with retinitis pigmentosa RP have macular edema swelling in the central retina This can cause decreased central vision The cause of macular edema is unknown but may involve inflammation The drug minocycline might help prevent inflammation and therefore might help treat macular edema and improve central visual function
Objectives
- To see if minocycline helps people with RP and macular edema
Eligibility
- People 12 years and older with RP who have macular edema in at least on eye
Design
Participants will be screened with medical and eye disease history They will have an eye exam and blood tests One eye with macular edema will be the study eye If both eyes are affected one will be designated the study eye
Participants will visit the clinic at least 9 times over at least 14 months The first 3 study visits will be monthly then every 2 months
Participants will start taking minocycline after visit 3 They will take 1 pill twice daily for at least 1 year
Participants will keep a medicine diary and bring it to each visit with their pill bottle and unused pills
At each study visit participants will have some or all of the following tests
eye and thyroid exams
blood and pregnancy tests
microperimetry participants will press a button when they see a light on a computer screen
visual field measurement participants will look at spots on a white screen to test side vision
electroretinogram A person will be dark adapted by sitting in the dark for 30 minutes After the placement of numbing eye drops special contact lenses will be placed The participant will watch flashing lights and recordings will be made
Detailed Description:
Objective
Retinitis pigmentosa RP is a broad category of genetically heterogeneous diseases involving progressive visual loss by a constriction of visual field and loss of night vision In up to one-third of patients the peripheral vision loss can be compounded by central visual acuity loss from the development of cystic macular changes While RP is a genetic disease the etiology of progressive cell death including that of associated cystoid macular edema CME is not completely understood Inflammatory processes involving the activation of resident immune cells of the retina called microglia have been hypothesized to contribute Minocycline inhibits the activation of microglia decreasing the production of inflammatory factors implicated in RP progression The objective of this study is to investigate the safety and possible efficacy of oral minocycline in participants with CME and RP
Study Population
Five participants ages 12 and older with unilateral or bilateral CME associated with RP will be enrolled initially However up to an additional five participants may be enrolled to replace participants who may withdraw from the study prior to reaching the Month 6 visit
Design
This is a pilot single-center uncontrolled open-label prospective Phase 12 clinical trial to evaluate minocycline as a potential treatment for CME secondary to RP A pre-treatment phase lasting two months will be instituted prior to investigational product IP initiation to assess the anatomical variability of CME as well as variability of other measurable parameters as part of the natural history of the disease Participants will receive an oral dose of 100 mg or appropriate weight adjusted pediatric dose of minocycline twice daily for 12 months There will be a common termination date which will take place when the last recruited participant has received 12 months of IP Participants who were recruited in the earlier part of the study will continue taking IP and be followed every two months until the common termination date At each visit participants will have visual acuity measured and will undergo optical coherence tomography OCT testing to measure retinal thickness Measures of central visual field sensitivity full-field electroretinograms ERG and microperimetry MP-1 will also be collected
Outcome Measures
The primary outcome is the change in CME based on OCT measurements in the study eye at 6 months compared to pre-treatment values Secondary outcomes include changes in OCT thickness changes in amplitude of photopic and scotopic responses on ERG testing changes in microperimetry and changes in visual field as measured by HVF 30-2 visual field testing at 6 months and 12 months compared to pre-treatment values as well as CME changes on OCT at 12 months compared to pre-treatment values Pre-treatment measurements will be analyzed to measure the natural variability of the CME as well as to measure the variability of the functional testing Safety outcomes will include the number and severity of adverse events AEs Ocular safety outcomes will be indicated by changes in visual acuity ocular surface changes intraocular inflammation and any other ocular changes not consistent with the natural progression of RP
Retinitis pigmentosa RP is a broad category of genetically heterogeneous diseases involving progressive visual loss by a constriction of visual field and loss of night vision In up to one-third of patients the peripheral vision loss can be compounded by central visual acuity loss from the development of cystic macular changes While RP is a genetic disease the etiology of progressive cell death including that of associated cystoid macular edema CME is not completely understood Inflammatory processes involving the activation of resident immune cells of the retina called microglia have been hypothesized to contribute Minocycline inhibits the activation of microglia decreasing the production of inflammatory factors implicated in RP progression The objective of this study is to investigate the safety and possible efficacy of oral minocycline in participants with CME and RP
Study Population
Five participants ages 12 and older with unilateral or bilateral CME associated with RP will be enrolled initially However up to an additional five participants may be enrolled to replace participants who may withdraw from the study prior to reaching the Month 6 visit
Design
This is a pilot single-center uncontrolled open-label prospective Phase 12 clinical trial to evaluate minocycline as a potential treatment for CME secondary to RP A pre-treatment phase lasting two months will be instituted prior to investigational product IP initiation to assess the anatomical variability of CME as well as variability of other measurable parameters as part of the natural history of the disease Participants will receive an oral dose of 100 mg or appropriate weight adjusted pediatric dose of minocycline twice daily for 12 months There will be a common termination date which will take place when the last recruited participant has received 12 months of IP Participants who were recruited in the earlier part of the study will continue taking IP and be followed every two months until the common termination date At each visit participants will have visual acuity measured and will undergo optical coherence tomography OCT testing to measure retinal thickness Measures of central visual field sensitivity full-field electroretinograms ERG and microperimetry MP-1 will also be collected
Outcome Measures
The primary outcome is the change in CME based on OCT measurements in the study eye at 6 months compared to pre-treatment values Secondary outcomes include changes in OCT thickness changes in amplitude of photopic and scotopic responses on ERG testing changes in microperimetry and changes in visual field as measured by HVF 30-2 visual field testing at 6 months and 12 months compared to pre-treatment values as well as CME changes on OCT at 12 months compared to pre-treatment values Pre-treatment measurements will be analyzed to measure the natural variability of the CME as well as to measure the variability of the functional testing Safety outcomes will include the number and severity of adverse events AEs Ocular safety outcomes will be indicated by changes in visual acuity ocular surface changes intraocular inflammation and any other ocular changes not consistent with the natural progression of RP
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14-EI-0108 | OTHER | NIH Combined NeuroScience Institutional Review Board | None |