A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion
NCT ID: NCT02153476
Last Updated: 2018-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2014-02-28
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2.0mg of ALG-1001
2.0mg of ALG-1001
2.0mg of ALG-1001
Intravitreal injection in 0.05cc balanced salt solution.
Balanced Salt Solution
Balanced Salt Solution
Interventions
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2.0mg of ALG-1001
Balanced Salt Solution
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Allegro Ophthalmics, LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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VMA-202
Identifier Type: -
Identifier Source: org_study_id