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Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Choroidal Neovascularization in Angioid Streaks in Young Patients (ASTRID).

NCT02573038 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-01-06

No results posted yet for this study

Summary

Angioid streaks are rare lesions associated to retinal pigment epithelium degenerations.

They can be caused by general diseases as pseudoxanthoma elasticum, Paget's disease or drepanocytosis. Choroidal neovascularization (CNV) represents the most frequent complication for those patients. It leads to a rapid and important loss of visual acuity. CNV in angioid streaks represent the fourth leading cause of CNV in young patients.

CNV in angioid streaks is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated in AMD. Case reports suggest that such patients would not need as many injections as in AMD.

ASTRID is an open-label, single arm, prospective, multicenter, phase II study. The main objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment with aflibercept on the visual acuity of patients affected by CNV in angioid streaks. A specific dosage regimen is designed to achieve maximum efficiency. The patients are followed on a monthly basis until 52 weeks. Six injections are mandatory, the other ones are injected only in case of active CNV.

Conditions

  • Choroidal Neovascularization in Angioid Streaks

Interventions

DRUG

Aflibercept

The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept at a dosage of 2 mg are initiated at inclusion (mandatory injection) followed by mandatory injections at week 4, week 8, week 20, week 32 and week 44. During the other visits, an injection can be performed in case of CNV activity (PRN regimen).Therefore, each patient receives between 6 and 13 injections in the whole study.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-05-31
Completion
2018-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02573038 on ClinicalTrials.gov