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

NCT02153476 | Completed Phase 2 Results DMC

• 1 other identifier: VMA-202
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Symptomatic Focal Vitreomacular Adhesion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

2.0mg of ALG-1001

EXPERIMENTAL

2.0mg of ALG-1001

Drug: 2.0mg of ALG-1001

Intravitreal injection in 0.05cc balanced salt solution.

PLACEBO COMPARATOR

Balanced Salt Solution

Drug: Balanced Salt Solution

Interventions

2.0mg of ALG-1001 DRUG

2.0mg of ALG-1001

Balanced Salt Solution DRUG

Intravitreal injection in 0.05cc balanced salt solution.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allegro Ophthalmics, LLC: lead

Study Sites (5)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Center for Retinal and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Consultants Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

risuteganib; Hanks Balanced Salt Solution

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Allegro Ophthalmics, LLC

lkarageozian@allegroeye.com

949-444-5722

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 3, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 19, 2018
• Results First Posted: July 18, 2018

Record last verified: 2018-11

Locations

US (5)