Choroidal Neovascularization in Angioid StreaksPhase 2ASTRIDNCT02573038
Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Choroidal Neovascularization in Angioid Streaks in Young Patients (ASTRID).
A Phase 2 study testing Aflibercept in people with Choroidal Neovascularization in Angioid Streaks, run by Hospices Civils de Lyon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Choroidal Neovascularization in Angioid Streaks
- What is being tested?
- Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 < 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
Who cannot join
- 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
Show all 28Show fewer
- 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
- Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments
- Aphakia or lack of lens capsule (not removed by YAG laser) in the studied eye
- Arterial hypertension that is not controlled by an appropriate treatment and defined by one measure of systolic blood pressure > 180mmHG or 2 consecutive measures > 160mmHg, or by a diastolic blood pressure > 100mmHg
- Antecedents of cerebrovascular disease or myocardial infarction during the last 6 months before inclusion (J1)
- Antecedents of any pathology, metabolic disease, or any serious suspicion of disease during the clinical or laboratory exam that would contraindicate the use of the product, could affect the interpretation of the study results or lead to major risks of complication for the subject
- Renal insufficiency requiring dialysis or renal transplantation
- Previous (less than a year) or actual treatment with systemic administration of anti-VEGF therapy
- Known hypersensitivity to aflibercept, or another drug composite of the medicinal product used; allergy to fluorescein, indocyanine green, anaesthetic eye drops
- Active or suspected ocular or peri-ocular infection
- Active severe intraocular inflammation
- Medical history of intra-ocular surgery within 28 days before the first injection in the studied eye
- Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion
- Follow up not possible during 12 months
About this study
Official title: Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Choroidal Neovascularization in Angioid Streaks in Young Patients.
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.
Read more
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.
- Being tested
- Aflibercept
- Keywords
- Aflibercept, choroidal neovascularization, angioid streaks, young patient
- Medical subject headings
- Choroidal Neovascularization, Angioid Streaks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Experimental | Intravitreal injection of aflibercept (EYLEA) / 2mg Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks
Secondary outcomes (9)
Mean change in BCVA from baseline to 24 weeks
Mean change in BCVA expressed as number of letters gained or lost measured with ETDRS scale from baseline to week 24
Measured: 24 weeks
Percentage of patients who lost fewer than 15 letters of BCVA from baseline to 24 weeks.
percentage of the patients who lost fewer than 15 letters of BCVA measured with ETDRS scale from baseline to week 24.
Measured: 24 weeks
Percentage of patients who lost fewer than 15 letters of BCVA from baseline to 52 weeks
Percentage of the patients who lost fewer than 15 letters of BCVA measured with ETDRS scale from baseline to week 52.
Measured: 52 weeks
number of injections per patient for 52 weeks
Measured: 52 weeks
Average change in central retinal thickness (CRT) between baseline and 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
Measured: 24 weeks
Average change in central retinal thickness (CRT) between baseline and 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
Measured: 52 weeks
Mean change in neovascular lesion size between baseline and 52 weeks.
change in neovascular lesion size measured with fluorescein and/or indocyanine green angiography from baseline to week 52
Measured: 52 weeks
Mean change in neovascular lesion morphology between baseline and 52 weeks.
Mean change in neovascular lesion morphology measured with fluorescein and/or indocyanine green angiography from baseline to week 52
Measured: 52 weeks
Side-effects observed during the study
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal Neovascularization in Angioid StreaksStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573038
- Sponsor's protocol ID
- 2014.878
- Other IDs
- 2014-003661-18, 2014
- Acronym
- ASTRID
- Status last verified
- Jan 2017
- First submitted
- 7 Oct 2015
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Choroidal Neovascularization in Angioid Streaks in Young Patients.
- ClinicalTrials.gov ID
- NCT02573038
- Acronym / sponsor ID
- ASTRID / 2014.878
- Keywords
- Aflibercept, choroidal neovascularization, angioid streaks, young patient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Experimental | Drug: AfliberceptIntravitreal injection of aflibercept (EYLEA) / 2mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 < 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
Key exclusion criteria (28 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfliberceptThe 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. | Drug | Aflibercept |
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
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.
9 secondary outcomes
Mean change in BCVA from baseline to 24 weeks
Time frame: 24 weeks
Percentage of patients who lost fewer than 15 letters of BCVA from baseline to 24 weeks.
Time frame: 24 weeks
Percentage of patients who lost fewer than 15 letters of BCVA from baseline to 52 weeks
Time frame: 52 weeks
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) between baseline and 52 weeks
Time frame: 52 weeks
Mean change in neovascular lesion size between baseline and 52 weeks.
Time frame: 52 weeks
Mean change in neovascular lesion morphology between baseline and 52 weeks.
Time frame: 52 weeks
Side-effects observed during the study
Time frame: 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aflibercept in people with Choroidal Neovascularization in Angioid Streaks, run by Hospices Civils de Lyon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.