Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 18, 2018
Sponsor:
Information provided by (Responsible Party):
Allegro Ophthalmics, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Symptomatic Focal Vitreomacular Adhesion
Interventions Drug: 2.0mg of ALG-1001
Drug: Balanced Salt Solution
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 2.0mg of ALG-1001 Intravitreal Injection in 0.05cc BSS
Hide Arm/Group Description

2.0mg of ALG-1001

2.0mg of ALG-1001

Balanced Salt Solution

Balanced Salt Solution

Period Title: Overall Study
Started 23 22
Completed 22 22
Not Completed 1 0
Arm/Group Title 2.0mg of ALG-1001 Intravitreal Injection in 0.05cc BSS Total
Hide Arm/Group Description

2.0mg of ALG-1001

2.0mg of ALG-1001

Balanced Salt Solution

Balanced Salt Solution

Total of all reporting groups
Overall Number of Baseline Participants 23 22 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  91.3%
18
  81.8%
39
  86.7%
>=65 years
2
   8.7%
4
  18.2%
6
  13.3%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants 22 participants 45 participants
49
(25 to 70)
49
(25 to 70)
49
(25 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 22 participants 45 participants
Female
11
  47.8%
10
  45.5%
21
  46.7%
Male
12
  52.2%
12
  54.5%
24
  53.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants 22 participants 45 participants
23
 100.0%
22
 100.0%
45
 100.0%
1.Primary Outcome
Title Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.0mg of ALG-1001 Intravitreal Injection in 0.05cc BSS
Hide Arm/Group Description:

2.0mg of ALG-1001

2.0mg of ALG-1001

Balanced Salt Solution

Balanced Salt Solution

Overall Number of Participants Analyzed 23 22
Measure Type: Count of Participants
Unit of Measure: Participants
4
  17.4%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2.0mg of ALG-1001 Intravitreal Injection in 0.05cc BSS
Hide Arm/Group Description

2.0mg of ALG-1001

2.0mg of ALG-1001

Balanced Salt Solution

Balanced Salt Solution

All-Cause Mortality
2.0mg of ALG-1001 Intravitreal Injection in 0.05cc BSS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/22 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
2.0mg of ALG-1001 Intravitreal Injection in 0.05cc BSS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2.0mg of ALG-1001 Intravitreal Injection in 0.05cc BSS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/22 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research
Organization: Allegro Ophthalmics, LLC
Phone: 949-444-5722
EMail: lkarageozian@allegroeye.com
Layout table for additonal information
Responsible Party: Allegro Ophthalmics, LLC
ClinicalTrials.gov Identifier: NCT02153476     History of Changes
Other Study ID Numbers: VMA-202
First Submitted: May 27, 2014
First Posted: June 3, 2014
Results First Submitted: April 26, 2018
Results First Posted: July 18, 2018
Last Update Posted: December 18, 2018