Under construction – not a live service
Sign in

2026-526775-27-00Not yet recruitingPhase 2

Evaluating Aganirsen Eye Drops to Reduce the Number of Aflibercept Injections in Wet Age-Related Macular Degeneration Patients.

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Aug 2026

Next steps

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
162 (estimated)
First submitted
13 May 2026
Start date
31 Aug 2026
Lead sponsor
Laboratoires Kol
EU CT number
2026-526775-27-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 162
  • 16 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Who has received topical corticosteroids or topical non-steroidal anti-inflammatory drugs in the study eye within the past 28 days

Other illness

  • 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,

Other

  • Who has significant ocular media opacities in the study eye that might interfere with BCVA assessment, OCT imaging or safety assessment

Who the study is looking for

  • Participant aged ≥ 50 and ≤ 89 years old
  • With a documented diagnosis of wAMD in the study eye
  • Who received at least one intravitreal injection, in the study eye, within 48 months after 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (16)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1FranceNot yet recruiting
Assistance Publique Hopitaux De ParisBobigny CedexFranceNot yet recruiting
Selarl Retine TournyBordeauxFranceNot yet recruiting
Centre hospitalier Universitaire de BordeauxBordeauxFranceNot yet recruiting
Centre Hospitalier Intercommunal CréteilCréteilFranceNot yet recruiting
Hospital Edouard HerriotLyonFranceNot yet recruiting
Hospices Civils De LyonLyon Cedex 04FranceNot yet recruiting
Centre Monticelli Paradis d'OphtalmologieMarseilleFranceNot yet recruiting
Clinique Honoré CaveMontaubanFranceNot yet recruiting
Institut Ophtalmologique De l Ouest Jules VerneNantesFranceNot yet recruiting
Centre Hospitalier Universitaire de NiceNiceFranceNot yet recruiting
RetinaSaint-Cyr-Sur-LoireFranceNot yet recruiting
Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-JarezFranceNot yet recruiting
Ophtalmologie Maison Rouge S.C.M.StrasbourgFranceNot yet recruiting
Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9FranceNot yet recruiting
Cabinet Du Docteur Jeremie HalfonToursFranceNot yet recruiting

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.