Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3) (ATTRACT)
Primary Purpose
Type 3 Choroidal Neovascularization
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Type 3 Choroidal Neovascularization
Eligibility Criteria
Inclusion Criteria:
- Males or females aged more than 50 years
- Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT
- Exudation on SD-OCT scans defined by intraretinal cysts or subretinal fluid.
- Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS)
- Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality
Exclusion Criteria:
- Any contraindications as reported in the labelling of Aflibercept (Eylea®): Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity.
- Any previous history of intravitreal injections in the study eye for exudative AMD
- Any secondary chorioretinal anastomosis due to retinal scar or fibrosis
- Any history of vitrectomy
- Media opacities preventing accurate imaging of the retina (cataract)
- Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole)
- Confirmed intraocular pressure ≥25 mmHg or non-stable glaucoma.
Sites / Locations
- Poitiers University Hospital
- Polyclinic of POITIERS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aflibercept
Arm Description
Outcomes
Primary Outcome Measures
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters
Secondary Outcome Measures
Full Information
NCT ID
NCT02320474
First Posted
December 10, 2014
Last Updated
March 7, 2019
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02320474
Brief Title
Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)
Acronym
ATTRACT
Official Title
Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 25, 2014 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 3 Choroidal Neovascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aflibercept
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Primary Outcome Measure Information:
Title
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Description
Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females aged more than 50 years
Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT
Exudation on SD-OCT scans defined by intraretinal cysts or subretinal fluid.
Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS)
Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality
Exclusion Criteria:
Any contraindications as reported in the labelling of Aflibercept (Eylea®): Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity.
Any previous history of intravitreal injections in the study eye for exudative AMD
Any secondary chorioretinal anastomosis due to retinal scar or fibrosis
Any history of vitrectomy
Media opacities preventing accurate imaging of the retina (cataract)
Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole)
Confirmed intraocular pressure ≥25 mmHg or non-stable glaucoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas LEVEZIEL, MD, PhD
Organizational Affiliation
CHU Poitiers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Polyclinic of POITIERS
City
Poitiers
ZIP/Postal Code
86000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)
We'll reach out to this number within 24 hrs