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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Choroidal Neovascularization in Angioid Streaks in Young Patients.

Brief 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.

Detailed Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome: Mean change in best corrected visual acuity (BCVA) from baseline to 52 weeks in patients with choroidal neovascularization in angioid streaks treated with Aflibercept [ Time Frame: 52 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Mean change in BCVA from baseline to 24 weeks [ Time Frame: 24 weeks ]
  Mean change in BCVA expressed as number of letters gained or lost measured with ETDRS scale from baseline to week 24
• Percentage of patients who lost fewer than 15 letters of BCVA from baseline to 24 weeks. [ Time Frame: 24 weeks ]
  percentage of the patients who lost fewer than 15 letters of BCVA measured with ETDRS scale from baseline to week 24.
• Percentage of patients who lost fewer than 15 letters of BCVA from baseline to 52 weeks [ Time Frame: 52 weeks ]
  Percentage of the patients who lost fewer than 15 letters of BCVA measured with ETDRS scale from baseline to week 52.
• number of injections per patient for 52 weeks [ Time Frame: 52 weeks ]
• Average change in central retinal thickness (CRT) between baseline and 24 weeks [ Time Frame: 24 weeks ]
  Average change in central retinal thickness (CRT) in micrometers measured with Spectral domain Optical Coherence Tomography (SD-OCT) from baseline to week 24
• Average change in central retinal thickness (CRT) between baseline and 52 weeks [ Time Frame: 52 weeks ]
  Average change in central retinal thickness (CRT) in micrometers measured with Spectral domain Optical Coherence Tomography (SD-OCT) from baseline to week 52
• Mean change in neovascular lesion size between baseline and 52 weeks. [ Time Frame: 52 weeks ]
  change in neovascular lesion size measured with fluorescein and/or indocyanine green angiography from baseline to week 52
• Mean change in neovascular lesion morphology between baseline and 52 weeks. [ Time Frame: 52 weeks ]
  Mean change in neovascular lesion morphology measured with fluorescein and/or indocyanine green angiography from baseline to week 52
• Side-effects observed during the study [ Time Frame: 52 weeks ]

Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: October 7, 2015
Date Started: February 2016
Date Completion: May 2018
Last Updated: January 5, 2017
Last Verified: January 2017