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
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
- Diseases
- Macular degeneration
- 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
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Amiens Picardie | Amiens Cedex 1 | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris | Bobigny Cedex | France | Not yet recruiting |
| Selarl Retine Tourny | Bordeaux | France | Not yet recruiting |
| Centre hospitalier Universitaire de Bordeaux | Bordeaux | France | Not yet recruiting |
| Centre Hospitalier Intercommunal Créteil | Créteil | France | Not yet recruiting |
| Hospital Edouard Herriot | Lyon | France | Not yet recruiting |
| Hospices Civils De Lyon | Lyon Cedex 04 | France | Not yet recruiting |
| Centre Monticelli Paradis d'Ophtalmologie | Marseille | France | Not yet recruiting |
| Clinique Honoré Cave | Montauban | France | Not yet recruiting |
| Institut Ophtalmologique De l Ouest Jules Verne | Nantes | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nice | Nice | France | Not yet recruiting |
| Retina | Saint-Cyr-Sur-Loire | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Saint Etienne | Saint-Priest-en-Jarez | France | Not yet recruiting |
| Ophtalmologie Maison Rouge S.C.M. | Strasbourg | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Toulouse | Toulouse Cedex 9 | France | Not yet recruiting |
| Cabinet Du Docteur Jeremie Halfon | Tours | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.