Inflammatory Choroidal NeovascularizationPhase 2ALINEANCT02556229
Study Evaluating the Efficacy of Aflibercept for the Treatment of Inflammatory CNV in Young Patients (ALINEA).
A Phase 2 study testing Aflibercept in people with Inflammatory Choroidal Neovascularization, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Inflammatory choroidal neovascularization (InCNV) is the third cause of CNV after myopia and Age-related Macular Degeneration (AMD). InCNV is a rare but severe disease and its treatment should not be delayed. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Inflammatory Choroidal Neovascularization
- 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
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Sep 2019
- 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 < 60 years old
- Patient who give voluntary signed informed consent
- Patient affiliated with the French universal health care system or similar
- Patient with inflammatory CNV, whatever the cause, including multifocal choroiditis, punctate inner choroidopathy, ocular toxoplasmosis, serpiginous choroiditis or Birdshot chorioretinopathy 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-inflammatory CNV, especially:
- AMD
Show all 28Show fewer
- drusen associated with neovessel
- High myopia defined as refraction ≥ - 6 diopters
- Other curative treatment of inflammatory CNV 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 (yttrium aluminium garnet) 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Inflammatory Choroidal Neovascularization (CNV) in Young Patients.
Inflammatory choroidal neovascularization (InCNV) is the third cause of CNV after myopia and Age-related Macular Degeneration (AMD). InCNV is a rare but severe disease and its treatment should not be delayed.
InCNV 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.
ALINEA 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 InCNV. A specific dosage regimen is designed to achieve maximum efficiency. The patients are followed on a monthly basis until 52 weeks. The first injection is mandatory. The other ones are injected only in case of active InCNV.
- Being tested
- Aflibercept
- Keywords
- Aflibercept, inflammatory choroidal neovascularization, young patient
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) with reinjection every 4 weeks only in case of CNV activity (PRN regimen) until 52 weeks.Therefore, each patient receives between 1 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) expressed as number of letters gained or lost measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scale from baseline to week 52
BCVA is measured on the ETDRS scale at an initial distance of 4 meters
Measured: 52 weeks
Secondary outcomes (10)
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 with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 24
Measured: 24 weeks
Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 52
Measured: 52 weeks
Number of injections per patient
Measured: 52 weeks
Mean time between 2 injections
Measured: 52 weeks
Mean 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
Mean 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 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
Mean change in neovascular lesion morphology measured with fluorescein and/or indocyanine green angiography from baseline to week 52
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 posted22 Sep 2015 (estimated)
- Study startJun 2016
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Choroidal NeovascularizationStudies 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
- 20 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
- NCT02556229
- Sponsor's protocol ID
- 69HCL14_0201
- Other IDs
- 2014-003695-23, 2014
- Acronym
- ALINEA
- Status last verified
- Aug 2025
- First submitted
- 18 Sep 2015
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kodjikian L, Abukhashabah A, Fardeau C, Tadayoni R, Brezin A, Dumas S, Weber M, Bernard L, Loria O, Decullier E, Huot L, Mathis T. Efficacy and safety of Aflibercept for the treatment of inflammatory choroidal neovascularization: The ALINEA study. Acta Ophthalmol. 2023 Feb;101(1):e43-e49. doi: 10.1111/aos.15214. Epub 2022 Jul 13.
PubMed 35822428
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. 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 Inflammatory Choroidal Neovascularization (CNV) in Young Patients.
- ClinicalTrials.gov ID
- NCT02556229
- Acronym / sponsor ID
- ALINEA / 69HCL14_0201
- Keywords
- Aflibercept, inflammatory choroidal neovascularization, young patient
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 22 Sep 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.
Inflammatory choroidal neovascularization (InCNV) is the third cause of CNV after myopia and Age-related Macular Degeneration (AMD). InCNV is a rare but severe disease and its treatment should not be delayed.
InCNV 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.
ALINEA 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 InCNV. A specific dosage regimen is designed to achieve maximum efficiency. The patients are followed on a monthly basis until 52 weeks. The first injection is mandatory. The other ones are injected only in case of active InCNV.
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 < 60 years old
- Patient who give voluntary signed informed consent
- Patient affiliated with the French universal health care system or similar
- Patient with inflammatory CNV, whatever the cause, including multifocal choroiditis, punctate inner choroidopathy, ocular toxoplasmosis, serpiginous choroiditis or Birdshot chorioretinopathy 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-inflammatory 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) with reinjection every 4 weeks only in case of CNV activity (PRN regimen) until 52 weeks.Therefore, each patient receives between 1 and 13 injections in the whole study. | Drug | Aflibercept |
Primary outcome
Mean change in best-corrected visual acuity (BCVA) expressed as number of letters gained or lost measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scale from baseline to week 52
Time frame: 52 weeks
BCVA is measured on the ETDRS scale at an initial distance of 4 meters
10 secondary outcomes
Mean change in BCVA expressed as number of letters gained or lost measured with ETDRS scale from baseline to week 24
Time frame: 24 weeks
Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 24
Time frame: 24 weeks
Percentage of patients with a <15-letter loss in BCVA measured with ETDRS scale from baseline to week 52
Time frame: 52 weeks
Number of injections per patient
Time frame: 52 weeks
Mean time between 2 injections
Time frame: 52 weeks
Mean change in central retinal thickness (CRT) in micrometers measured with Spectral Domain - Optical Coherence Tomography (SD-OCT) from baseline to week 24
Time frame: 24 weeks
Mean change in central retinal thickness (CRT) in micrometers measured with Spectral Domain - Optical Coherence Tomography (SD-OCT) from baseline to week 52
Time frame: 52 weeks
Mean change in neovascular lesion size measured with fluorescein and/or indocyanine green angiography from baseline to week 52
Time frame: 52 weeks
Side-effects observed during the study
Time frame: 52 weeks
Mean change in neovascular lesion morphology measured with fluorescein and/or indocyanine green angiography from baseline to week 52
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Results publication: PubMed 35822428Kodjikian L, Abukhashabah A, Fardeau C, Tadayoni R, Brezin A, Dumas S, Weber M, Bernard L, Loria O, Decullier E, Huot L, Mathis T. Efficacy and safety of Aflibercept for the treatment of inflammatory choroidal neovascularization: The ALINEA study. Acta Ophthalmol. 2023 Feb;101(1):e43-e49. doi: 10.1111/aos.15214. Epub 2022 Jul 13.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aflibercept in people with Inflammatory Choroidal Neovascularization, run by Hospices Civils de Lyon at 1 site in France.
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: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) expressed as number of letters gained or lost measured with Early Treatment Diabetic Retinopathy Study (ETDRS) scale from baseline to week 52 (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02556229, which also lists 1 linked publication.
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 8 Aug 2025.