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Repeated Eye Injections of Aflibercept for Treatment of Wet Age Related Macular Degeneration (ATLAS)

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: NCT01773954
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : May 2, 2018
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
MidAtlantic Retina, Wills Eye

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Age-Related Macular Degeneration
Macular Degeneration
Intervention Drug: Intravitreal Aflibercept Injection
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intravitreal Aflibercept
Hide Arm/Group Description Intravitreal aflibercept on treat and extend schedule
Period Title: Overall Study
Started 40
Completed 31
Not Completed 9
Arm/Group Title Intravitreal Aflibercept
Hide Arm/Group Description Intravitreal aflibercept on treat and extend schedule
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
81.3  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
23
  57.5%
Male
17
  42.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants
40
1.Primary Outcome
Title Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score
Hide Description [Not Specified]
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravitreal Aflibercept
Hide Arm/Group Description:
Intravitreal aflibercept on treat and extend schedule
Overall Number of Participants Analyzed 40
Mean (95% Confidence Interval)
Unit of Measure: letters
7.2
(2.9 to 11.6)
2.Other Pre-specified Outcome
Title Change in Total Thickness at the Foveal Center Point on OCT
Hide Description [Not Specified]
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravitreal Aflibercept
Hide Arm/Group Description:
Intravitreal aflibercept on treat and extend schedule
Overall Number of Participants Analyzed 40
Mean (95% Confidence Interval)
Unit of Measure: micrometers
-143
(-187 to -99)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravitreal Aflibercept
Hide Arm/Group Description Intravitreal aflibercept on treat and extend schedule
All-Cause Mortality
Intravitreal Aflibercept
Affected / at Risk (%)
Total   2/40 (5.00%) 
Hide Serious Adverse Events
Intravitreal Aflibercept
Affected / at Risk (%)
Total   2/40 (5.00%) 
Cardiac disorders   
Fatal MI   1/40 (2.50%) 
Eye disorders   
Endophthalmitis   1/40 (2.50%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravitreal Aflibercept
Affected / at Risk (%)
Total   0/40 (0.00%) 
This is a non-controlled, non-comparative open label study.
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: Michele Formoso
Organization: Mid Atlantic Retina
Phone: 215-928-3092
EMail: research@midatlanticretina.com
Layout table for additonal information
Responsible Party: MidAtlantic Retina, Wills Eye
ClinicalTrials.gov Identifier: NCT01773954    
Other Study ID Numbers: ATLAS
20122054 ( Other Identifier: Western Institutional Review Board )
First Submitted: January 17, 2013
First Posted: January 23, 2013
Results First Submitted: October 6, 2017
Results First Posted: May 2, 2018
Last Update Posted: May 2, 2018