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Clinical Trials in Germany / NCT05300724
Active, not recruiting Observational

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

NCT05300724 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2022-05-27
Last updated
2026-09-16

Condition(s) studied

Age-Related Macular Degeneration

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention will be administered in this study.

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
94 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
Retina Partners of Northwest Arkansas, PLLC Springdale Arkansas
The Retina Partners Encino California
Retina Consultants of Orange County Fullerton California
Northern California Retina Vitreous Associates Mountain View California
Retina Consultants, San Diego Poway California
UC Davis Eye Center Sacramento California
Retinal Consultants Medical Group Sacramento California
Bay Area Retina Associates Walnut Creek California
Southwest Retina Consultants Durango Colorado
Eye Care Center of Northern Colorado PC Longmont Colorado
Advanced Research Coral Springs Florida
Rand Eye Institute Deerfield Beach Florida
National Ophthalmic Research Institute Fort Myers Florida
Florida Eye Associates Melbourne Florida
Southeast Retina Center Augusta Georgia
University Retina and Macula Associates, PC Oak Forest Illinois
Raj K. Maturi, MD PC Indianapolis Indiana
Wolfe Eye Clinic West Des Moines Iowa
Cumberland Valley Retina Consultants PC Hagerstown Maryland
New England Retina Consultants Springfield Massachusetts
Foundation for Vision Research Grand Rapids Michigan
Deep Blue Retina Clinical Research Southaven Mississippi
Sierra Eye Associates Reno Nevada
Eye Associates of New Mexico Albuquerque New Mexico
Vitreous Retina Macula Consultants of New York New York New York
Ophthalmic Consultants of Long Island Rockville Centre New York
Duke Eye Center Durham North Carolina
Cleveland Clinic Cole Eye Institute Cleveland Ohio
Retina Vitreous Center Edmond Oklahoma
EyeHealth Northwest Portland Oregon
Casey Eye Institute - OHSU Portland Oregon
Erie Retinal Surgery Erie Pennsylvania
Scheie Eye Institute Philadelphia Pennsylvania
Palmetto Retina Center, LLC West Columbia South Carolina
Tennessee Retina PC Nashville Tennessee
W Texas Retina Consultants PA Abilene Texas
Austin Retina Associates Austin Texas
Austin Clinical Research LLC Austin Texas
Retina Consultants of Texas Bellaire Texas
Retina Foundation of the Southwest Dallas Texas

+ 34 more sites — see the full list on the official registry below.

More Genentech, Inc. trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05300724 on ClinicalTrials.gov ↗ ← All trials in Germany