Ignite Creation Date:
2024-05-05 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00766649
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2008-10-03
Brief Title:
Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral GA Associated With AMD
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2014-04
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:
SIRGA
Brief Summary:
This study will determine if a drug called sirolimus is safe to give to people with geographic atrophy GA and if it can help preserve vision in patients GA is an advanced form of dry age-related macular degeneration AMD AMD affects the macula the central part of the retina needed for sharp clear vision There are two types of AMD wet and dry In dry AMD cells in the macula dieGA may at least partly be caused by inflammation Sirolimus helps prevent inflammation and therefore may help treat GA
People with GA in both eyes with visual acuity between 2020 and 20400 in each eye may be eligible for this study Participants undergo the following tests and procedures
Sirolimus injections in the study eye at each 3-month clinic visit The drug is injected under the outer layer of the eye after the patient receives antiseptic and numbing drops Antibiotic drops are continued for 2 days after the injection
Eye examinations before the first injection 1 month after the first injection during each clinic visit 11 to 15 visits over 2 to 3 years and 3 months after the final injection The examination includes testing visual acuity measuring eye pressure and checking eye movements To examine the inside of the eye the pupil is dilated with eye drops Regular photographs of the inside of the eye and optical coherence tomography photographs which allow measurement of the thickness of the retina may be taken during the eye examination
Autofluorescence imaging The patient sits in a chair with his or her head placed in a chin rest in front of a camera A light in the camera is used to scan the eye
Blood tests Blood is drawn at the first visit and at up to seven study visits to check blood chemistries such as liver and kidney function
Urine pregnancy test for women who are able to become pregnant
People with GA in both eyes with visual acuity between 2020 and 20400 in each eye may be eligible for this study Participants undergo the following tests and procedures
Sirolimus injections in the study eye at each 3-month clinic visit The drug is injected under the outer layer of the eye after the patient receives antiseptic and numbing drops Antibiotic drops are continued for 2 days after the injection
Eye examinations before the first injection 1 month after the first injection during each clinic visit 11 to 15 visits over 2 to 3 years and 3 months after the final injection The examination includes testing visual acuity measuring eye pressure and checking eye movements To examine the inside of the eye the pupil is dilated with eye drops Regular photographs of the inside of the eye and optical coherence tomography photographs which allow measurement of the thickness of the retina may be taken during the eye examination
Autofluorescence imaging The patient sits in a chair with his or her head placed in a chin rest in front of a camera A light in the camera is used to scan the eye
Blood tests Blood is drawn at the first visit and at up to seven study visits to check blood chemistries such as liver and kidney function
Urine pregnancy test for women who are able to become pregnant
Detailed Description:
Objective Age-related macular degeneration AMD the leading cause of blindness in people over age 55 in the United States is a heterogeneous clinical entity in which retinal degeneration occurs predominantly in the macula in the context of aging and leads to impairment of central visual acuity AMD occurs in two general forms one of which involves choroidal neovascularization CNV with subsequent formation of a disciform scar This is often referred to as the neovascular or wet form A second form the subject of this study is termed dry or atrophic macular degeneration and involves a constellation of clinical features that can include drusen pigment clumping andor retinal pigment epithelium RPE dropout and geographic atrophy GA GA can begin as a thinning of the RPE with involvement of the underlying choriocapillaris and lead subsequently to an atrophic change in the macula Inflammation may play a role in the pathogenesis of GA Sirolimus inhibits the production signaling and activity of many inflammatory factors relevant to the development of GA Therefore the objective of this study is to investigate the safety and possible efficacy of multiple sirolimus subconjunctival injections in participants with bilateral GA
Study Population Ten participants with bilateral GA associated with AMD with the potential to replace up to five participants if some fail to reach one year of follow-up
Design In this controlled unmasked Phase III study one eye of eligible participants will be randomized to treatment while the fellow eye will be observed Participants will receive a 20 μL 440 μg subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter The study will be completed once all participants have received two years of study medication and follow-up
Outcome Measures The primary outcome is the rate of change in area of GA based on masked grading by an external Reading Center of fundus photography in the study eye and fellow eye at two years compared with baseline Secondary outcomes will include worsening of best-corrected visual acuity BCVA of three or more lines 15 or more letters changes in area of GA as measured on autofluorescence changes in drusen volume as measured by optical coherence tomography changes in photoreceptor outer segment PROS thickness as measured by optical coherence tomography as well as changes in drusen area based on masked digital grading of fundus photographs Safety outcomes will include the number and severity of systemic and ocular toxicities adverse events and infections
Study Population Ten participants with bilateral GA associated with AMD with the potential to replace up to five participants if some fail to reach one year of follow-up
Design In this controlled unmasked Phase III study one eye of eligible participants will be randomized to treatment while the fellow eye will be observed Participants will receive a 20 μL 440 μg subconjunctival injection of sirolimus in the study eye at baseline and every three months thereafter The study will be completed once all participants have received two years of study medication and follow-up
Outcome Measures The primary outcome is the rate of change in area of GA based on masked grading by an external Reading Center of fundus photography in the study eye and fellow eye at two years compared with baseline Secondary outcomes will include worsening of best-corrected visual acuity BCVA of three or more lines 15 or more letters changes in area of GA as measured on autofluorescence changes in drusen volume as measured by optical coherence tomography changes in photoreceptor outer segment PROS thickness as measured by optical coherence tomography as well as changes in drusen area based on masked digital grading of fundus photographs Safety outcomes will include the number and severity of systemic and ocular toxicities adverse events and infections
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 |
|---|---|---|---|
| 09-EI-0008 | REGISTRY | National Institutes of Health Clinical Center | None |