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

Symptomatic Focal Vitreomacular Adhesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153476
• Other study ID #: VMA-202
• Status: Completed
• Phase: Phase 2
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2018
• Source: Allegro Ophthalmics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Symptomatic Focal Vitreomacular Adhesion
• Tissue Adhesions

Intervention

Drug:
• 2.0mg of ALG-1001

• Balanced Salt Solution

Locations

Country	Name	City	State
United States	Austin Retina Associates	Austin	Texas
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Retina Consultants Houston	Houston	Texas
United States	California Retina Consultants	Santa Barbara	California
United States	Center for Retinal and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allegro Ophthalmics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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