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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02153476
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : July 18, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Allegro Ophthalmics, LLC

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

Condition or disease Intervention/treatment Phase
Symptomatic Focal Vitreomacular Adhesion Drug: 2.0mg of ALG-1001 Drug: Balanced Salt Solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion
Study Start Date : February 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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Arm Intervention/treatment
Experimental: 2.0mg of ALG-1001
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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153476


Locations
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United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
California Retina Consultants
Santa Barbara, California, United States, 93103
United States, Florida
Center for Retinal and Macular Disease
Winter Haven, Florida, United States, 33880
United States, Texas
Austin Retina Associates
Austin, Texas, United States, 78705
Retina Consultants Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Allegro Ophthalmics, LLC
More Information
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Responsible Party: Allegro Ophthalmics, LLC
ClinicalTrials.gov Identifier: NCT02153476    
Other Study ID Numbers: VMA-202
First Posted: June 3, 2014    Key Record Dates
Results First Posted: July 18, 2018
Last Update Posted: December 19, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes