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

Allegro Ophthalmics

Status and phase: Completed; Phase 2

Conditions: Symptomatic Focal Vitreomacular Adhesion

Treatments: Drug: Balanced Salt Solution; Drug: 2.0mg of ALG-1001

Study type: Interventional

Funder types: Industry

Identifiers

NCT02153476

VMA-202

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

2.0mg of ALG-1001

Experimental group

Description:

2.0mg of ALG-1001

Treatment:

Drug: 2.0mg of ALG-1001

Intravitreal injection in 0.05cc balanced salt solution.

Placebo Comparator group

Description:

Balanced Salt Solution

Treatment:

Drug: Balanced Salt Solution