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

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

Study Overview

• Status: Completed
• Conditions: Symptomatic Focal Vitreomacular Adhesion
• Intervention / Treatment: Drug: 2.0mg of ALG-1001; Drug: Balanced Salt Solution

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
  • Florida
    • Winter Haven, Florida, United States, 33880
      • Center for Retinal and Macular Disease
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Houston, Texas, United States, 77030
      • Retina Consultants Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2.0mg of ALG-1001	Drug: 2.0mg of ALG-1001
Placebo Comparator: Intravitreal injection in 0.05cc balanced salt solution.; Balanced Salt Solution	Drug: Balanced Salt Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)	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.	90 Days

Collaborators and Investigators

• Sponsor: Allegro Ophthalmics, LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: VMA-202