Informations générales (source: ClinicalTrials.gov)
A Multicenter, Prospective, Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
Observational
Genentech, Inc. (Voir sur ClinicalTrials)
mai 2022
juin 2027
02 octobre 2025
This is a multicenter prospective study in participants with intermediate age-related
macular degeneration (iAMD). One primary objective of this study is to assess iAMD
disease progression, by the timeline and rates of conversion for high-risk iAMD at
baseline to more advanced atrophic AMD stages. The other primary objective of this
observational study is to assess the feasibility of measuring the rate of photoreceptor
loss as a potential clinical endpoint. The study will consist of an observation period of
approximately 3 years (~144 weeks) for participants.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Eric SOUIED | 29/03/2024 01:30:15 | Contacter | ||
| HOPITAL FONDATION A. DE ROTHSCHILD | Ramin TADAYONI | 21/06/2024 13:34:52 | Contacter | ||
Critères
Tous
- For women of childbearing potential, agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception, during the study for at least 28
days after the last fluorescein injection for the fluorescein angiography (FA)
administration
- Study eye: High-risk intermediate AMD
Exclusion Criteria:
- Macular disease in either eye with subretinal deposits not typical of AMD
- Pigmentary abnormalities of the retina in either eye not typical of AMD
- Atrophy in either eye due to causes other than AMD
- Study eye: Any concurrent or history of ocular or intraocular condition
- Study eye: Intraocular surgery, including cataract surgery, within 3 months prior to
Day 1
- Study eye: Retinal tears or peripheral retinal breaks within 3 months prior to Day 1
- Study eye: Concurrent or history of retinal laser photocoagulation or anti-vascular
endothelial growth factor (anti-VEGF) treatment for exudative MNV, diabetic macular
edema, retinal vein occlusion, or proliferative diabetic retinopathy
- Study eye: Presence of choroidal nevus with overlying drusen in the circle with a
radius 3600 micrometer centered on the fovea
- Study eye: Previous participation in interventional clinical trials for GA or early
stages of AMD, except for vitamins and minerals, regardless of the route of
administration within the last 6 months, except for sham-arm participants
- Study eye: History of glaucoma surgery, corneal transplant, retinal pigment
epithelium tear, retinal tear that involves the macula, retinal detachment
- Either eye: Uncontrolled progressive glaucoma
- Either eye: Moderate or severe non-proliferative diabetic retinopathy or
proliferative diabetic retinopathy
- Either eye: History of recurrent infectious or inflammatory ocular disease
- Any concurrent or history of taking medications that can induce retinal toxicity