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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2015

Interventions

  • Drug: 2.0mg of ALG-1001
  • Drug: Balanced Salt Solution

Arms, Groups and Cohorts

  • Experimental: 2.0mg of ALG-1001
    • 2.0mg of ALG-1001
  • Placebo Comparator: Intravitreal injection in 0.05cc balanced salt solution.
    • Balanced Salt Solution

Clinical Trial Outcome Measures

Primary Measures

  • Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)
    • Time Frame: 90 Days
    • The primary endpoint of this study is observation of pharmacologic resolution of VMA, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field surrounded by elevation of the posterior vitreous cortex as seen on OCT.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allegro Ophthalmics, LLC
  • Provider of Information About this Clinical Study
    • Sponsor

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