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

Phase 2

Completed

• Conditions: Symptomatic Focal Vitreomacular Adhesion
• Interventions: Drug: 2.0mg of ALG-1001; Drug: Balanced Salt Solution

• Registration Number: NCT02153476
• Lead Sponsor: Allegro Ophthalmics, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2018-04-26
• Results First Submitted QC: 2018-06-21
• Results First Posted: 2018-07-18
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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

Primary Outcome Measures

Name	Time	Method
Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)	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.

Trial Locations

Locations (5)

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