Sirolimus Versus Anti-Vascular Endothelial Growth Factor (antiVEGF) for Wet AMD

Age-Related Macular Degeneration Clinical Trial

Official title:

Sirolimus Versus AntiVEGF for Wet AMD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357342
• Other study ID #: RKM008
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2015
• Last updated: June 20, 2017
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: Maturi, Raj K., M.D., P.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous AntiVEGF treatment.

Description:

Forty subjects will be randomized to receive intravitreal Sirolimus or standard of care treatment in a 1:1 ratio. Over the course of the six month trial plus a 6 month optional extension, subjects will be evaluated monthly. Treatment with Sirolimus will be given at baseline, month 2 and month 4 with sham injections given at months 1, 3 and 5. For subjects in the extension Sirolimus will also be given at months 6, 8 and 10 with sham at month 7, 9, and 11. Subjects in the standard of care group will receive anti-VEGF injections or sham monthly. Retreatment criteria will be based upon continued subretinal edema, intraretinal edema or active chorioretinal neovascularization (CNV)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• best corrected visual acuity of 5-65, inclusive, in study eye

• presence of choroid neovascularization secondary to AMD

• persistent edema despite at least 3 previous intravitreal anti-VEGF injections in the past 5 months

Exclusion Criteria:

• greater than 100 micron decrease in central subfield thickness on Optical Coherence Topography (OCT) since last standard of care visit

• history of major ophthalmic surgery in the study eye in the past 3 months

• history of significant ocular disease or condition other than exudative AMD that may confound results

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Sirolimus
intravitreal injection
• Standard of Care intravitreal injections of anti-VEGF
intravitreal injections of anti-VEGF

Locations

Country	Name	City	State
United States	Raj K Maturi MD PC	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Maturi, Raj K., M.D., P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography	Change in edema from baseline to month 6 as measured by mean difference in microns of central subfield thickness on Heidelberg optical coherence topography in each treatment group	Baseline to 6 months
Primary	Visual Acuity	number of subjects with gain of 0-4 letters of visual acuity	Baseline to 6 months
Secondary	Visual Acuity (Best Corrected Visual Acuity)	number of subjects with gain of 5 or more letters of visual acuity	baseline to 6 months