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

NCT02573038 | Withdrawn Phase 2 DMC

• 2 other identifiers: 2014.8782014-003661-18
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Choroidal Neovascularization in Angioid Streaks

Keywords

Aflibercept; choroidal neovascularization; angioid streaks; young patient

Outcome Measures

Primary Outcomes (1)

• Mean change in best corrected visual acuity (BCVA) from baseline to 52 weeks in patients with choroidal neovascularization in angioid streaks treated with Aflibercept

  Change in BCVA number of letters gained or lost between baseline and 52 weeks. BCVA is measured on the scale Early Treatment Diabetic Retinopathy Study (ETDRS) at an initial distance of 4 meters.

  52 weeks

Secondary Outcomes (9)

• Mean change in BCVA from baseline to 24 weeks

  24 weeks

• Percentage of patients who lost fewer than 15 letters of BCVA from baseline to 24 weeks.

  24 weeks

• Percentage of patients who lost fewer than 15 letters of BCVA from baseline to 52 weeks

  52 weeks

• number of injections per patient for 52 weeks

  52 weeks

• Average change in central retinal thickness (CRT) between baseline and 24 weeks

  24 weeks

Study Arms (1)

Aflibercept

EXPERIMENTAL

Intravitreal injection of aflibercept (EYLEA) / 2mg

Drug: Aflibercept

Interventions

Aflibercept DRUG

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.

Aflibercept

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \< Age \< 50 years old
• Patient who give voluntary signed informed consent
• Patient affiliated with the French universal health care system or similar
• Patient with CNV in angioid streaks, whatever caused the angioid streaks, with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography (fluorescein and/or indocyanine green) and/or SD-OCT in the studied eye
• Patient willing, committed and able to return for all clinic visits and complete all study-related procedures

You may not qualify if:

• Pregnant women
• Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
• Patient who is protected adults according to the terms of the law (French public health laws)
• Involvement in another clinical trial (studied eye and/or the other eye)
• Patient with non-angioid streaks CNV, especially:
• AMD
• High myopia defined as refraction ≥ - 6 diopters
• Other curative treatment of CNV in angioid streaks in the studied eye during the last 3 months before the first intravitreal injection: anti-VEGF therapy, juxta- or extra-foveal macular laser, photodynamic therapy, surgery, external radiotherapy, transpupillary thermotherapy ...
• Medical history of retrofoveal focal macular laser photocoagulation in the studied eye
• Subretinal hemorrhage reaching the fovea center or with a size \> 50% of the lesion area
• Fibrosis or retrofoveal retinal atrophy in the studied eye
• Retinal pigment epithelial tear reaching the macula in the studied eye
• Medical history of intravitreal medical device in the studied eye
• Medical history of auto-immune or idiopathic uveitis
• Proved diabetic retinopathy

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Choroidal Neovascularization; Angioid Streaks

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 9, 2015
• Study Start: February 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: January 6, 2017

Record last verified: 2017-01