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Completed

NCT Number: NCT02153476

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

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Key information

Conditions

Symptomatic Focal Vitreomacular Adhesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retina-Vitreous Associates Medical Group, Beverly Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2.0mg of ALG-1001

Drug

balanced salt solution

Drug

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Allegro Ophthalmics, LLC

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2014
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.