CompletedPhase 2

A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion

United States45 participantsStarted 2014-02

Plain-language summary

Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Symptomatic focal vitreomacular adhesion
✓. Vitreomacular traction syndrome
✓. Stage 1 and 2 macular holes, ≤ 350 µm
✓. BCVA of 20/25 Early Treatment Diabetic Retinopathy Study (ETDRS) or worse in the study eye
✓. BCVA of 20/800 ETDRS or better in the fellow eye
✓. Male or female subjects, 18 years of age or older
✓. Signed Informed Consent

✕. High myopes \> -8.0 D spherical equivalent
✕. History of prior vitrectomy in the study eye
✕. History of photocoagulation to the retina in the study eye
✕. Macular hole in the study eye \> 350 µm
✕. Subjects with epiretinal membranes in the study eye
✕. Subjects with broad VMA, defined as VMA of \>1500 µm
✕. Subjects with proliferative Diabetic Retinopathy (DR), neovascular Age-related Macular Degeneration (AMD), or retinal vascular occlusion in the study eye
✕. Subjects with aphakia in the study eye

Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)

Timeframe: 90 Days

NCT IDNCT02153476

SponsorAllegro Ophthalmics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

Results submitted2018-04-26