CompletedPhase 1

A Study of Implantation of Retinal Pigment Epithelium in Subjects with Acute Wet Age Related Macular Degeneration

United Kingdom9 participantsStarted 2021-10-14

Plain-language summary

Phase 1 trial of retinal pigment epithelium replacement in subjects with wet age-related macular degeneration in whom there is rapidly progressing vision loss

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and /or post-menopausal female subjects aged 60 years or above. * Diagnosis of wet Age-related Macular Degeneration (AMD) plus rapid recent vision decline * An informed consent document signed and dated by the subject or a legal representative. Exclusion Criteria: * Pregnant females; breastfeeding females; and females of childbearing potential. * Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. * Current or previous significant other ocular disease in the study eye, as determined by the investigator.

What they're measuring

Incidence and severity of adverse events.

Timeframe: 52 weeks

Change in baseline in ETDRS best corrected visual acuity (BCVA) - Proportion of subjects with an improvement of 15 letters or more at Week 24.

Timeframe: 24 weeks

Trial details

NCT IDNCT01691261

SponsorMoorfields Eye Hospital NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-10

View on ClinicalTrials.gov More Age Related Macular Degeneration trials