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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allegro Ophthalmics, LLC
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Symptomatic focal vitreomacular adhesion

2. Vitreomacular traction syndrome

3. Stage 1 and 2 macular holes, ≤ 350 µm

4. BCVA of 20/25 Early Treatment Diabetic Retinopathy Study (ETDRS) or worse in the study eye

5. BCVA of 20/800 ETDRS or better in the fellow eye

6. Male or female subjects, 18 years of age or older

7. Signed Informed Consent

Exclusion Criteria:

1. High myopes > -8.0 D spherical equivalent

2. History of prior vitrectomy in the study eye

3. History of photocoagulation to the retina in the study eye

4. Macular hole in the study eye > 350 µm

5. Subjects with epiretinal membranes in the study eye

6. Subjects with broad VMA, defined as VMA of >1500 µm

7. Subjects with proliferative Diabetic Retinopathy (DR), neovascular Age-related Macular Degeneration (AMD), or retinal vascular occlusion in the study eye

8. Subjects with aphakia in the study eye

9. Subjects with uncontrolled glaucoma

10. Subjects with lenticular or zonular instability

11. Subjects with prior ocular surgery or intravitreal injection in the study eye within 90 days of study enrollment

12. Pregnant or nursing women