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Trial Outcomes & Findings for A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion (NCT NCT02153476)

NCT ID: NCT02153476

Last Updated: 2018-12-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

90 Days

Results posted on

2018-12-19

Participant Flow

Participant milestones

Participant milestones
Measure
2.0mg of ALG-1001
2.0mg of ALG-1001 2.0mg of ALG-1001
Intravitreal Injection in 0.05cc BSS
Balanced Salt Solution Balanced Salt Solution
Overall Study
STARTED
23
22
Overall Study
COMPLETED
22
22
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
2.0mg of ALG-1001
n=23 Participants
2.0mg of ALG-1001 2.0mg of ALG-1001
Intravitreal Injection in 0.05cc BSS
n=22 Participants
Balanced Salt Solution Balanced Salt Solution
Total
n=45 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
21 Participants
n=5 Participants
18 Participants
n=7 Participants
39 Participants
n=5 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
Age, Continuous
49 years
n=5 Participants
49 years
n=7 Participants
49 years
n=5 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
10 Participants
n=7 Participants
21 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
12 Participants
n=7 Participants
24 Participants
n=5 Participants
Region of Enrollment
United States
23 Participants
n=5 Participants
22 Participants
n=7 Participants
45 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
2.0mg of ALG-1001
n=23 Participants
2.0mg of ALG-1001 2.0mg of ALG-1001
Intravitreal Injection in 0.05cc BSS
n=22 Participants
Balanced Salt Solution Balanced Salt Solution
Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)
4 Participants
0 Participants

Adverse Events

2.0mg of ALG-1001

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intravitreal Injection in 0.05cc BSS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Research

Allegro Ophthalmics, LLC

Phone: 949-444-5722

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place