Evaluating Aganirsen Eye Drops to Reduce the Number of Aflibercept Injections in Wet Age-Related Macular Degeneration Patients.
Key facts
- Where
- Amiens Cedex 1, Bobigny Cedex, Bordeaux, Créteil, Lyon, Lyon Cedex 04, Marseille, Montauban, Nantes, Nice, Saint-Cyr-Sur-Loire, Saint-Priest-en-Jarez, Strasbourg, Toulouse Cedex 9 és Tours, FranciaországSee the 16 sites
- Phase
- 2. fázis
Where in Franciaország
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranciaországTaking people
- Assistance Publique Hopitaux De ParisBobigny Cedex, FranciaországTaking people
- Centre hospitalier Universitaire de BordeauxBordeaux, FranciaországTaking people
- Selarl Retine TournyBordeaux, FranciaországTaking people
- Centre Hospitalier Intercommunal CréteilCréteil, FranciaországTaking people
- Hospital Edouard HerriotLyon, FranciaországTaking people
- Hospices Civils De LyonLyon Cedex 04, FranciaországTaking people
- Centre Monticelli Paradis d'OphtalmologieMarseille, FranciaországTaking people
- Clinique Honoré CaveMontauban, FranciaországTaking people
- Institut Ophtalmologique De l Ouest Jules VerneNantes, FranciaországTaking people
- Centre Hospitalier Universitaire de NiceNice, FranciaországTaking people
- RetinaSaint-Cyr-Sur-Loire, FranciaországTaking people
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranciaországTaking people
- Ophtalmologie Maison Rouge S.C.M.Strasbourg, FranciaországTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranciaországTaking people
- Cabinet Du Docteur Jeremie HalfonTours, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Laboratoires Kol
- Trial code
- EU 2026-526775-27-00
- Record updated
- 2026. augusztus 10.
- Original description
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 periodRead full original descriptionShow less
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
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
Inclusion: 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.
Exclusion: 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.