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

Primary Purpose

Symptomatic Focal Vitreomacular Adhesion

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
2.0mg of ALG-1001
Balanced Salt Solution
Sponsored by
Allegro Ophthalmics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Focal Vitreomacular Adhesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina-Vitreous Associates Medical Group
  • California Retina Consultants
  • Center for Retinal and Macular Disease
  • Austin Retina Associates
  • Retina Consultants Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2.0mg of ALG-1001

Intravitreal injection in 0.05cc balanced salt solution.

Arm Description

2.0mg of ALG-1001

Balanced Salt Solution

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 27, 2014
Last Updated
November 27, 2018
Sponsor
Allegro Ophthalmics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02153476
Brief Title
A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion
Official Title
A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allegro Ophthalmics, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Focal Vitreomacular Adhesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2.0mg of ALG-1001
Arm Type
Experimental
Arm Description
2.0mg of ALG-1001
Arm Title
Intravitreal injection in 0.05cc balanced salt solution.
Arm Type
Placebo Comparator
Arm Description
Balanced Salt Solution
Intervention Type
Drug
Intervention Name(s)
2.0mg of ALG-1001
Intervention Type
Drug
Intervention Name(s)
Balanced Salt Solution
Primary Outcome Measure Information:
Title
Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)
Description
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.
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Center for Retinal and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Consultants Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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