Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100009
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-12-21
Brief Title:
Triamcinolone Acetonide Plus Laser Therapy to Treat Age-Related Macular Degeneration
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Multi-Center Randomized Phase IIIII Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide as an Adjunct to Photodynamic Therapy in Participants With Neovascular Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2006-12-20
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:
This study will test the safety and effectiveness of combining a laser treatment called photodynamic therapy or PDT with injections into the eye of the steroid triamcinolone acetonide for treating age-related macular degeneration AMD The macula is the part of the retina in the back of the eye that determines central or best vision AMD can severely impair central vision affecting a persons ability to read drive and carry out daily activities This vision loss is caused by the formation of abnormal blood vessels behind the retina that leak blood under the macula PTD stops the growth of these blood vessels and slows the rate of vision loss however it has only a temporary effect and does not work in all patients Furthermore it may actually cause some swelling and re-growth of blood vessels Triamcinolone acetonide can help lessen swelling and scarring
Patients 50 years of age and older with AMD may be eligible for this study Candidates are screened with a medical history medical evaluation and eye examinations see below Participants are randomly assigned to one of three treatment groups 1 PDT plus 1 mg TAC-PF 2 PDT plus 4 mg TAC-PF or 3 PDT plus sham injection a syringe with no needle is pressed against the eye Treatments are given the day the patient enrolls in the study and then every 3 months for 2 years as long as the therapy is thought beneficial Patients who must discontinue TAC-PF injections may still be treated with PDT if medically necessary In addition to treatment patients undergo the following tests and procedures
Eye examination Visual acuity and eye pressure are measured and the lens retina pupils and eye movements are examined
Fundus photography Photographs of the back of the eye are taken using a special camera with a bright flash
Lens photography Photographs of the lens are taken to look for development of cataracts
Fluorescein angiography Pictures of the retina are taken to look for abnormal blood vessels A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes The retina is photographed using a camera that flashes a blue light into the eye The pictures show if any dye has leaked from the vessels into the retina indicating possible blood vessel abnormality
Optical coherence tomography This test uses light to produce a 2-dimensional cross-sectional picture of the retina The patient looks into a machine called an optical coherence tomograph at a pattern of flashing and rotating red and green lights first with one eye and then the other
PDT A needle is placed in an arm vein and a drug called verteporfin Visudyne Registered Trademark is infused into the vein over 10 minutes After 15 minutes the eye is anesthetized with numbing drops A special contact lens is then placed on the eye and the laser beam is directed to the eye for 83 seconds
TAC-PF or injections for those in the TAC-PF treatment groups Numbing and anesthetic drops are placed on the surface of the eye before injection of TAC-PF Another anesthetic is then applied to the lower part of the eye with a cotton swab After a few minutes TAC-PF is injected into the vitreous jelly-like substance inside the eye Patients receiving sham injections undergo the identical procedure except a syringe with no needle is pressed against the eye to seem like a real injection All patients receive antibiotic drops to put in their eye for 2 days after each treatment Patients return to the clinic anytime from 2 to 7 days after each treatment for a check of vision eye pressure and treatment side effects
Patients are seen in the clinic for additional checks at 4 weeks and 4 months after the first treatment
Patients 50 years of age and older with AMD may be eligible for this study Candidates are screened with a medical history medical evaluation and eye examinations see below Participants are randomly assigned to one of three treatment groups 1 PDT plus 1 mg TAC-PF 2 PDT plus 4 mg TAC-PF or 3 PDT plus sham injection a syringe with no needle is pressed against the eye Treatments are given the day the patient enrolls in the study and then every 3 months for 2 years as long as the therapy is thought beneficial Patients who must discontinue TAC-PF injections may still be treated with PDT if medically necessary In addition to treatment patients undergo the following tests and procedures
Eye examination Visual acuity and eye pressure are measured and the lens retina pupils and eye movements are examined
Fundus photography Photographs of the back of the eye are taken using a special camera with a bright flash
Lens photography Photographs of the lens are taken to look for development of cataracts
Fluorescein angiography Pictures of the retina are taken to look for abnormal blood vessels A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes The retina is photographed using a camera that flashes a blue light into the eye The pictures show if any dye has leaked from the vessels into the retina indicating possible blood vessel abnormality
Optical coherence tomography This test uses light to produce a 2-dimensional cross-sectional picture of the retina The patient looks into a machine called an optical coherence tomograph at a pattern of flashing and rotating red and green lights first with one eye and then the other
PDT A needle is placed in an arm vein and a drug called verteporfin Visudyne Registered Trademark is infused into the vein over 10 minutes After 15 minutes the eye is anesthetized with numbing drops A special contact lens is then placed on the eye and the laser beam is directed to the eye for 83 seconds
TAC-PF or injections for those in the TAC-PF treatment groups Numbing and anesthetic drops are placed on the surface of the eye before injection of TAC-PF Another anesthetic is then applied to the lower part of the eye with a cotton swab After a few minutes TAC-PF is injected into the vitreous jelly-like substance inside the eye Patients receiving sham injections undergo the identical procedure except a syringe with no needle is pressed against the eye to seem like a real injection All patients receive antibiotic drops to put in their eye for 2 days after each treatment Patients return to the clinic anytime from 2 to 7 days after each treatment for a check of vision eye pressure and treatment side effects
Patients are seen in the clinic for additional checks at 4 weeks and 4 months after the first treatment
Detailed Description:
Age-related macular degeneration AMD represents the most common cause of blindness in persons over the age of 50 The major cause of vision loss in this disease is due to the development of choroidal neovascularization Several clinical trials have shown that eyes with neovascularization portending 4 disc areas or less or all lesions with predominately classic composition lesions having at least 50 of vessels which can be readily demarcated with fluorescein angiography can benefit from treatment with photodynamic therapy verteporfin - PDT However this treatment only results in a reduction in the number of participants who suffer moderate and severe vision loss Few participants demonstrate an improvement in visual acuity
Histopathologic studies have demonstrated the presence of an inflammatory response in the retina and choroid of participants with choroidal neovascularization as well as in eyes receiving verteporfin - PDT Therefore the use of triamcinolone acetonide which possesses anti-inflammatory as well as anti-angiogenic properties may be beneficial in participants with neovascular AMD undergoing verteporfin - PDT
This study will be organized as a controlled participant masked randomized multi-center Phase IIIII study that will investigate the efficacy of a preservative - free intravitreal formulation of triamcinolone acetonide TAC-PF in AMD participants undergoing verteporfin - PDT Unlike studies that use steroids containing benzyl alcohol this study will evaluate preservative-free steroids Three hundred participants with neovascular AMD undergoing verteporfin - PDT will be randomly assigned to receive either a sham intravitreal injection a 1 mg intravitreal injection of TAC-PF or a 4 mg intravitreal injection of TAC-PF Depending on a participants response treatments as randomized may be repeated at 3-month intervals Participants will complete a maximum of 2 years of follow-up
The primary efficacy outcome measure is the proportion of participants who experience a moderate vision loss defined as a drop of greater than or equal to 15 letters in best-corrected visual acuity from baseline verteporfin - PDT treatment to month 12 Secondary outcomes will include assessments of the safety of the adjunct therapy additional vision changes observed between baseline month 3 month 12 and month 24 lesion changes observed between baseline month 3 month 12 and month 24 and changes observed in lens opacities between baseline month 12 and month 24
Histopathologic studies have demonstrated the presence of an inflammatory response in the retina and choroid of participants with choroidal neovascularization as well as in eyes receiving verteporfin - PDT Therefore the use of triamcinolone acetonide which possesses anti-inflammatory as well as anti-angiogenic properties may be beneficial in participants with neovascular AMD undergoing verteporfin - PDT
This study will be organized as a controlled participant masked randomized multi-center Phase IIIII study that will investigate the efficacy of a preservative - free intravitreal formulation of triamcinolone acetonide TAC-PF in AMD participants undergoing verteporfin - PDT Unlike studies that use steroids containing benzyl alcohol this study will evaluate preservative-free steroids Three hundred participants with neovascular AMD undergoing verteporfin - PDT will be randomly assigned to receive either a sham intravitreal injection a 1 mg intravitreal injection of TAC-PF or a 4 mg intravitreal injection of TAC-PF Depending on a participants response treatments as randomized may be repeated at 3-month intervals Participants will complete a maximum of 2 years of follow-up
The primary efficacy outcome measure is the proportion of participants who experience a moderate vision loss defined as a drop of greater than or equal to 15 letters in best-corrected visual acuity from baseline verteporfin - PDT treatment to month 12 Secondary outcomes will include assessments of the safety of the adjunct therapy additional vision changes observed between baseline month 3 month 12 and month 24 lesion changes observed between baseline month 3 month 12 and month 24 and changes observed in lens opacities between baseline month 12 and month 24
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 |
|---|---|---|---|
| 05-EI-0064 | None | None | None |