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Active (not recruiting) NCT05300724

An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration

Conditions: Age-Related Macular Degeneration

Sponsor: Genentech, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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
Locations 7
Australia (1)
Marsden Eye Specialists
Parramatta , New South Wales
France (1)
Centre Hospitalier Intercommunal
Créteil
Germany (1)
Universitätsklinikum Bonn
Bonn
Israel (1)
Rambam Medical Center - PPDS
Haifa
Italy (1)
Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia
Udine , Friuli Venezia Giulia
Puerto Rico (1)
Emanuelli Research and Development Center LLC
Arecibo
United States (1)
Retina Partners of Northwest Arkansas, PLLC
Springdale , Arkansas
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
50 Years
Maximum age
94 Years
Healthy volunteers
No
Start date
27.05.2022
Completion date
30.06.2027
Registry ID
NCT05300724
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.