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Taking people in FrancePhase 2

Aganirsen Eye Drops to Space Out Aflibercept Injections in Wet Macular Degeneration

Tests aganirsen eye drops for lengthening time between aflibercept injections in wet macular degeneration.

Key facts

Who runs it
Laboratoires Kol
Where
Amiens Cedex 1, Bobigny Cedex, Bordeaux, Chamant, Créteil, Dijon, Lyon, Lyon Cedex 04, Marseille, Montauban, Nantes, Nice, Paris 5e Arrondissement, Saint-Cyr-Sur-Loire, Saint-Priest-en-Jarez, Strasbourg, Toulouse Cedex 9, Tours, and Valence, FranceSee the 20 sites
Registry title
Evaluating Aganirsen Eye Drops to Reduce the Number of Aflibercept Injections in Wet Age-Related Macular Degeneration Patients.
Status
Recruiting
Phase
Phase 2
People taking part
162 people, planned
Started
17 Sept 2026
Expected to end
31 Dec 2027
Type of study
Interventional
Record updated
12 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Participant aged ≥ 50 and ≤ 89 years old
  • With a documented diagnosis of wAMD in the study eye
  • Diagnosed with wAMD no more than 48 months before enrollment and who received at least one intravitreal injection in the study eye during the 48-month period following diagnosis
  • Currently treated with intravitreal aflibercept 8 mg according to a T&E dosing regimen, in the study eye
  • Absence of retinal fluid (i.e., no IRF and SRF), in the study eye, under the current intravitreal aflibercept treatment interval
  • With BCVA ≥ 1/10 in the study eye
  • Who reports being able to self-administer eye drops twice daily for 9 months or who reports having a caregiver available and able to administer him/her eye drops twice daily for 9 months
  • Who had experienced an unsuccessful extension of treatment (presence of fluid (i.e., presence of IRF or SRF)), following intravitreal aflibercept 8 mg according to a T&E dosing regimen, in the study eye, for at least 1 of the last 3 injections administered

Who cannot take part

  • Who has received topical corticosteroids or topical non-steroidal anti-inflammatory drugs in the study eye within the past 28 days
  • Who has a retinal disease other than wAMD in the study eye
  • Who has active, suspected or trace of recent ocular, periocular or intraocular infection or inflammation
  • Who has a recent history (within the past 6 months) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event
  • Who is deprived of liberty or under psychiatric care without their consent,
  • Who has significant ocular media opacities in the study eye that might interfere with BCVA assessment, OCT imaging or safety assessment

Where in France

  • Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranceTaking people
  • Assistance Publique Hopitaux De ParisBobigny Cedex, FranceTaking people
  • Centre hospitalier Universitaire de BordeauxBordeaux, FranceTaking people
  • Selarl Retine TournyBordeaux, FranceTaking people
  • Pole Oise OphtalmologieChamant, FranceTaking people
  • Centre Hospitalier Intercommunal CréteilCréteil, FranceTaking people
  • Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
  • Hospital Edouard HerriotLyon, FranceTaking people
  • Hospices Civils De LyonLyon Cedex 04, FranceTaking people
  • Centre Monticelli Paradis d'OphtalmologieMarseille, FranceTaking people
  • Clinique Honoré CaveMontauban, FranceTaking people
  • Institut Ophtalmologique De l Ouest Jules VerneNantes, FranceTaking people
  • Centre Hospitalier Universitaire de NiceNice, FranceTaking people
  • Centre Ophtalmologique Sorbonne Saint-MichelParis 5e Arrondissement, FranceTaking people
  • RetinaSaint-Cyr-Sur-Loire, FranceTaking people
  • Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranceTaking people
  • Ophtalmologie Maison Rouge S.C.M.Strasbourg, FranceTaking people
  • Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
  • Cabinet Du Docteur Jeremie HalfonTours, FranceTaking people
  • Centre Hospitalier ValenceValence, FranceTaking people

About the trial

What the trial wants to find out

To assess the efficacy of two doses of aganirsen in comparison to placebo, in terms of extension of intravitreal aflibercept 8 mg treatment interval over the 9-month treatment period

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Phase 2 Multicentric Randomized Double-Blinded Efficacy and Safety Clinical Trial Comparing Several Doses of Aganirsen Eye Drops Emulsion to Extend Intravitreal Aflibercept Treatment Interval in Wet Age-Related Macular Degeneration (wAMD) Patients - SKY2 Study
Plain-language title
Aganirsen Eye Drops to Space Out Aflibercept Injections in Wet Macular DegenerationGenerated from the registry record. The registry title is the official one.
Record updated
12 November 2026