Phase 2
N=45
A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion
Symptomatic Focal Vitreomacular Adhesion
Bottom Line
View on ClinicalTrials.gov: NCT02153476 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT) — 4; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 2.0mg of ALG-1001 (Drug); Balanced Salt Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allegro Ophthalmics, LLC
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT) |
4; 0 | — |
Summary
Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02153476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.