Macular DegenerationPhase 3ARI2NCT02157077
Aflibercept After Ranibizumab in Exudative Age-related Macular Degeneration
A Phase 3 study testing Aflibercept in people with Macular Degeneration and Wet Macular Degeneration, run by Centre Hospitalier Intercommunal Creteil at 9 sites in France.
Trial summary
The purpose of the current study is to evaluate the ability of Eylea to induce a regression of PED height on patients previously extensively treated by Lucentis. The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration
- 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
- 84 participants
- Where
- 9 sitesFrance
- Study dates
- Dec 2013to Dec 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 50 years of age
- Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD including juxtafoveal lesions that affect the fovea evidenced by Fluorescein Angiography in the study eye
- Patient having been treated for at least 12 months with Ranibizumab (≥ 8 injections)
- Patient with a PED > 250 µm, defined by spectral domain optical coherent tomography (SD-OCT), measured at two consecutive visits before inclusion with any persisting sub retinal fluid at baseline
- Patient affiliated to a social security scheme
- Signed Informed Consent
Who cannot join
- Patient with subfoveal atrophy and/or atrophy with a diameter greater than 150µm in the subfoveal or juxtafoveal area
- Patient with a subfoveal fibrosis
- Subretinal hemorrhage that is either 50 percent or more of the total lesion area or 1 or more disc areas in size in the study eye.
- Scar, fibrosis or atrophy making up > 50% of total lesion in the study eye.
- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
- History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
Show all 24Show fewer
- Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
- Any history of macular hole of stage 3 and above in the study eye.
- Uncontrolled glaucoma (defined as intraocular pressure ≥25 mmHg despite treatment with antiglaucoma medication) or prior laser treatment for glaucoma in the study eye.
- Active intraocular inflammation or uveitis of scleritis or episcleritis in the study eye or ocular or periocular infection in either eye
- Presence or history of scleromalacia in the study eye.
- Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye.
- Previous therapeutic radiation in the study eye.
- History of corneal transplant or corneal dystrophy in the study eye.
- Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of toxicity, or fundus photography.
- Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 24 month study period.
- Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
- Any systemic treatment with an investigational agent except dietary supplements or vitamins in the past 6 months prior to Day 1 for any condition.
- Any history of allergy to povidone iodine.
- Contraindications as listed
- Patient enrolled in another interventional research or not
- Patient already included in the study for the treatment of one of his eye
- Pregnant or nursing woman
- Lack of effective contraception for women of childbearing age
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hôpital Pellegrin
Bordeaux, 33000
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Hôpital général de Dijon
Dijon, 21033
Centre d'Ophtalmologie Rabelais
Lyon, 69003
Cabinet Alpes Rétine
Montbonnot-Saint-Martin, 38330
CHR Hôtel Dieu
Nantes, 44093
Centre d'explorations ophtalmologiques de l'odéon
Paris, 75006
Hôpital des Quinze-Vingts
Paris, 75012
Clinique Mathilde
Rouen, 76100
About this study
Official title: A Phase III b, Multicenter Study of the Efficacy and Safety of Aflibercept Switch in Patients With Exudative AMD With Detachment of the Retinal Pigment Epithelium and Previously Treated With Ranibizumab Intravitreal Injection. (ARI2)
The purpose of the current study is to evaluate the ability of Eylea to induce a regression of PED height on patients previously extensively treated by Lucentis.
The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.
Read the detailed description
The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.
- Conditions
- Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases
- Being tested
- Aflibercept
- Keywords
- Eye diseases, Vision Impairment and Blindness, Eyes and Vision, Seniors, Neovascular Age-Related Macular Degeneration (AMD), Retinal Disease
- Medical subject headings
- Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Also called Eylea, BAY86-5321
Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Experimental | Patients will receive 2 mg of aflibercept by intravitreal injection every 4 weeks until week 8, followed by every 6 weeks to week 26 Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Maximal Height of Pigment Epithelium Detachment (PED) at 12 Weeks
Measured: Baseline and 12 weeks
Secondary outcomes (8)
Change From Baseline in Central Retinal Thickness by SD OCT at 12 Weeks
Measured: Baseline and 12 weeks
Best-corrected Visual Acuity at 12 Weeks
Best-corrected visual acuity (BCVA) was measured using ETDRS letter scores.
Measured: 12 weeks
Pigment Epithelial Detachment Volume at 12 Weeks
Pigment epithelial detachment volume was assessed by SD-OCT and semiautomated volumetric analysis.
Measured: 12 weeks
Central Retinal Thickness at 32 Weeks
Measured: 32 weeks
Pigment Epithelium Detachment Height at 32 Weeks
Measured: 32 weeks
Visual Acuity at 32 Weeks
Measured: 32 weeks
Volume of Pigment Epithelium Detachment at 32 Weeks
Measured: 32 weeks
Pigment Epithelium Detachment Height at 12 Weeks
Maximal pigment epithelial detachment (PED) height was assessed by spectral-domain optical coherence tomography (SD-OCT).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Eric Souied, MD, Study director, Centre Hospitalier Intersommunal de Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157077
- Sponsor's protocol ID
- ARI2
- Other IDs
- 2013-002869-19
- Acronym
- ARI2
- Status last verified
- Oct 2026
- First submitted
- 2 Mar 2014
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mouallem-Beziere A, Blanco-Garavito R, Richard F, Miere A, Jung C, Rozet JM, Souied EH. GENETICS OF LARGE PIGMENT EPITHELIAL DETACHMENTS IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Apr;40(4):663-671. doi: 10.1097/IAE.0000000000002454.
PubMed 30681643
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III b, Multicenter Study of the Efficacy and Safety of Aflibercept Switch in Patients With Exudative AMD With Detachment of the Retinal Pigment Epithelium and Previously Treated With Ranibizumab Intravitreal Injection. (ARI2)
- ClinicalTrials.gov ID
- NCT02157077
- Acronym / sponsor ID
- ARI2 / ARI2
- Conditions
- Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases
- Keywords
- Eye diseases, Vision Impairment and Blindness, Eyes and Vision, Seniors, Neovascular Age-Related Macular Degeneration (AMD), Retinal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Posted 5 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current study is to evaluate the ability of Eylea to induce a regression of PED height on patients previously extensively treated by Lucentis.
The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.
Detailed description
The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.
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: AfliberceptPatients will receive 2 mg of aflibercept by intravitreal injection every 4 weeks until week 8, followed by every 6 weeks to week 26 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ≥ 50 years of age
- Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD including juxtafoveal lesions that affect the fovea evidenced by Fluorescein Angiography in the study eye
- Patient having been treated for at least 12 months with Ranibizumab (≥ 8 injections)
- Patient with a PED > 250 µm, defined by spectral domain optical coherent tomography (SD-OCT), measured at two consecutive visits before inclusion with any persisting sub retinal fluid at baseline
- Patient affiliated to a social security scheme
Key exclusion criteria (24 listed)
- Patient with subfoveal atrophy and/or atrophy with a diameter greater than 150µm in the subfoveal or juxtafoveal area
- Patient with a subfoveal fibrosis
- Subretinal hemorrhage that is either 50 percent or more of the total lesion area or 1 or more disc areas in size in the study eye.
- Scar, fibrosis or atrophy making up > 50% of total lesion in the study eye.
- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
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 |
|---|---|---|
| AfliberceptAlso: Eylea, BAY86-5321Intravitreal Injection | Drug | Aflibercept |
Primary outcome
Change From Baseline in Maximal Height of Pigment Epithelium Detachment (PED) at 12 Weeks
Time frame: Baseline and 12 weeks
8 secondary outcomes
Change From Baseline in Central Retinal Thickness by SD OCT at 12 Weeks
Time frame: Baseline and 12 weeks
Best-corrected Visual Acuity at 12 Weeks
Time frame: 12 weeks
Pigment Epithelial Detachment Volume at 12 Weeks
Time frame: 12 weeks
Central Retinal Thickness at 32 Weeks
Time frame: 32 weeks
Pigment Epithelium Detachment Height at 32 Weeks
Time frame: 32 weeks
Visual Acuity at 32 Weeks
Time frame: 32 weeks
Volume of Pigment Epithelium Detachment at 32 Weeks
Time frame: 32 weeks
Pigment Epithelium Detachment Height at 12 Weeks
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30681643Mouallem-Beziere A, Blanco-Garavito R, Richard F, Miere A, Jung C, Rozet JM, Souied EH. GENETICS OF LARGE PIGMENT EPITHELIAL DETACHMENTS IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Apr;40(4):663-671. doi: 10.1097/IAE.0000000000002454.
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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.
Eric Souied, MD study director
Centre Hospitalier Intersommunal de Créteil
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aflibercept in people with Macular Degeneration and Wet Macular Degeneration, run by Centre Hospitalier Intercommunal Creteil at 9 sites 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 6 inclusion and 24 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Maximal Height of Pigment Epithelium Detachment (PED) at 12 Weeks (time frame: Baseline and 12 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 NCT02157077, 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 27 Oct 2026.