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

Completed · Phase 2

Conditions studied: Symptomatic Focal Vitreomacular Adhesion

In brief

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

Key facts

Study ID

NCT02153476

Run by

Allegro Ophthalmics, LLC

People needed

45

Starts

2014-02-01

Expected to finish

2015-06-01

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Subjects with uncontrolled glaucoma
• Subjects with lenticular or zonular instability
• Subjects with prior ocular surgery or intravitreal injection in the study eye within 90 days of study enrollment
• Pregnant or nursing women

Where it is running

• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Center for Retinal and Macular Disease — Winter Haven, Florida, United States
• Austin Retina Associates — Austin, Texas, United States
• Retina Consultants Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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