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Completed

NCT Number: NCT02357342

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

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Raj K Maturi MD PC

Indianapolis, Indiana, 46290, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sirolimus

Drug

intravitreal injection

Other names: DE-109

Standard of Care intravitreal injections of anti-VEGF

Drug

intravitreal injections of anti-VEGF

Other names: avastin,bevacizumab, eylea, aflibercept,

Primary outcomes

  1. Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography

    Time frame: Baseline to 6 months

    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

  2. Visual Acuity

    Time frame: Baseline to 6 months

    number of subjects with gain of 0-4 letters of visual acuity

Secondary outcomes

  1. Visual Acuity (Best Corrected Visual Acuity)

    Time frame: baseline to 6 months

    number of subjects with gain of 5 or more letters of visual acuity

Sponsors and collaborators

Lead sponsor

Maturi, Raj K., M.D., P.C.

Indiv

Registry information

Official study title

Sirolimus Versus AntiVEGF for Wet AMD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 6, 2015
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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