ATTRACT: Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02320474
• Collaborator: (none)
• Enrollment: 26
• Locations: 2
• Arm: 1
• Actual Duration (Months): 47.2
• Patients Per Site: 13
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 3 Choroidal Neovascularization	Drug: Aflibercept	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)
• Actual Study Start Date: Nov 25, 2014
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aflibercept	Drug: Aflibercept

Outcome Measures

Primary Outcome Measures

1. Mean change from baseline in Best Corrected Visual Acuity (BCVA) [52 weeks]

   Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Poitiers University Hospital	Poitiers		France	86000
2	Polyclinic of POITIERS	Poitiers		France	86000

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

• Principal Investigator: Nicolas LEVEZIEL, MD, PhD, CHU Poitiers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT02320474
• Other Study ID Numbers: ATTRACT
• First Posted: Dec 19, 2014
• Last Update Posted: Mar 8, 2019
• Last Verified: Mar 1, 2019

• Additional relevant MeSH terms: Choroidal Neovascularization; Neovascularization, Pathologic; Aflibercept

Study Results

No Results Posted as of Mar 8, 2019