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Neovascular Age-related Macular Degeneration of All SubtypesPhase 4STARTNCT02246829

Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®)START

A Phase 4 study testing Intravitreal injection in people with Neovascular Age-related Macular Degeneration of All Subtypes, run by University Hospital, Bordeaux at 10 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for patients suffering from neovascular age-related-macular degeneration.1 This early dramatic reduction in CRT is already observed through week 4. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Intravitreal injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
10 sitesFrance
Study dates
Sep 2014to Jun 2015
Phase
Phase 4
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 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 affects the fovea as evidenced by FA in the study eye
  • Signed Informed Consent
  • Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.

Who cannot join

  • Prior treatment with anti-VEGF therapy in the study eye
  • Active or suspected ocular or periocular infection.
  • Active severe intraocular inflammation

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • Service d'ophtalmologie Hôpital Henri Mondor 40, avenue de Verdun

    Créteil, 94000

  • Service Ophtalmologie CHU DIJON 14 rue Gaffarel BP 77908

    Dijon, 21079

  • Service d'Ophtalmologie Hôpital de la croix rousse

    Lyon, 69317

  • Cabinet d'ophtalmologie 1 rue Pougin de la Maisonneuve

    Montargis, 45200

  • Sce Ophtalmologie CHU Nantes 1 place Alexis Ricordeau

    Nantes, 44093

  • Centre ophtalmique d'imagerie et de laser (CIL) 11 rue Antoine Bourdelle

    Paris, 75011

  • Sce du Pr SAHEL Fondation ROTHSCHILD 25 rue Manin

    Paris, 75019

  • Sce Ophtalmologie Hôpital Lariboisière 2 rue Ambroise Paré

    Paris, 75475

  • Service Opthalmo 2 Clinique Mathilde 4 rue de Lessard

    Rouen, 76100

  • Centre Ophtalmologie Transparence 30 Boulevard Heurteloup

    Tours, 37000

Other trials in France

About this study

Official title: Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®) (2mg) Over a 12-week Period for Patients Suffering From Neovascular Age-related Macular Degeneration (AMD) French SD OCT in wAMD

Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for patients suffering from neovascular age-related-macular degeneration.1 This early dramatic reduction in CRT is already observed through week 4. Therefore it might be not necessary to consistently perform each of the three monthly consecutive intravitreal injections of the so-called loading phase.

Read the detailed description

The aim of this study is to assess whether the retina of some patients has dried up after the first or second intravitreal injection of Aflibercept (EYLEA®) 2mg and in that event, to determine the proportion of these patients The analysis of the characteristics could help identify a morphotype that would predict whether and when the retina will dry up within the first 3 months of treatment. For some patients having an early drying-up, the third monthly injection might be not necessary 50 naïve patients will be included and will receive a monthly injection over 12 weeks with a biweekly follow-up. Morphological and functional characteristics will be recorded at each visit and will be analyzed. The rate of patients with dry SD-OCT will be assessed.

The study includes 7 visits. The visits are scheduled on an every 2-week basis from baseline to Week 12. V1 (baseline), V3 and V5, the patient will be injected with Aflibercept (EYLEA®) 2mg. In the other visits, the visual acuity test, Fundus photography, SD-OCT, and/or Fluorescein Angiography are performed

Being tested
Intravitreal injection
Keywords
wet AMD, SD-OCT, intravitreal injection, central retinal thickness,

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravitreal injectionProcedure or surgery

    2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period

Study groups in NCT02246829
Study groupRoleWhat they receive
Aflibercept 2mg Intravitreal injectionOther2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period
Receives: Procedure: Intravitreal injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurence of a Dry SD-OCT 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg

    Measured: 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg

Secondary outcomes (6)

  1. Time to get a dry SD-OCT after initiation of a treatment by Aflibercept

    Measured: Every 2 weeks from treatment initiation (inclusion) to week 12

  2. Evolution of morphological and visual modification under Aflibercept (EYLEA®)

    Measured: Every 2 weeks from treatment initiation (inclusion) to week 12

  3. Occurence of pigment epithelial detachment

    Measured: Every 2 weeks from treatment initiation (inclusion) to week 12

  4. Evolution of retinal hemorrhage if any

    Measured: Every 2 weeks from treatment initiation (inclusion) to week 12

  5. Evolution in the atrophic lesions

    Measured: Every 2 weeks from treatment initiation (inclusion) to week 12

  6. Occurence the central Retinal Thickness

    Measured: Every 2 weeks from treatment initiation (inclusion) to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02246829
Sponsor's protocol ID
CHUBX 2013/18
Other IDs
2013-005050-30
Acronym
START
Status last verified
Nov 2016
First submitted
11 Sep 2014
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No

Publications

  • Patel KH, Chow CC, Rathod R, Mieler WF, Lim JI, Ulanski LJ 2nd, Leiderman YI, Arun V, Chau FY. Rapid response of retinal pigment epithelial detachments to intravitreal aflibercept in neovascular age-related macular degeneration refractory to bevacizumab and ranibizumab. Eye (Lond). 2013 May;27(5):663-7; quiz 668. doi: 10.1038/eye.2013.31. Epub 2013 Apr 5.

    PubMed 23558214

  • Cruess AF, Zlateva G, Xu X, Soubrane G, Pauleikhoff D, Lotery A, Mones J, Buggage R, Schaefer C, Knight T, Goss TF. Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study. Pharmacoeconomics. 2008;26(1):57-73. doi: 10.2165/00019053-200826010-00006.

    PubMed 18088159

  • Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.

    PubMed 17021318

  • Cohen SY, Souied EH, Weber M, Dupeyron G, de Pouvourville G, Lievre M, Ponthieux A. Patient characteristics and treatment of neovascular age-related macular degeneration in France: the LUEUR1 observational study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):521-7. doi: 10.1007/s00417-010-1553-0. Epub 2010 Nov 6.

    PubMed 21057805

  • Heier JS, Boyer D, Nguyen QD, Marcus D, Roth DB, Yancopoulos G, Stahl N, Ingerman A, Vitti R, Berliner AJ, Yang K, Brown DM; CLEAR-IT 2 Investigators. The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. Ophthalmology. 2011 Jun;118(6):1098-106. doi: 10.1016/j.ophtha.2011.03.020.

    PubMed 21640258

  • Korobelnik JF, Souied EH, Oubraham H, Razavi S, Mauget-Faysse M, Savel H, Chene G, Wolf S. ASSESSMENT OF EARLY CHANGES IN SPECTRAL DOMAIN-OPTICAL COHERENCE TOMOGRAPHY AFTER INITIATION OF TREATMENT WITH INTRAVITREAL AFLIBERCEPT (EYLEA) OVER A 12-WEEK PERIOD FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Multicenter French Study (START). Retina. 2021 Mar 1;41(3):588-594. doi: 10.1097/IAE.0000000000002910.

    PubMed 33600134

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravitreal injection in people with Neovascular Age-related Macular Degeneration of All Subtypes, run by University Hospital, Bordeaux at 10 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 4 inclusion and 3 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Occurence of a Dry SD-OCT 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg (time frame: 12-week after initiation of a treatment by Aflibercept (EYLEA®) 2mg). 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 NCT02246829, which also lists 6 linked publications.

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 17 Sep 2026.

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