Clinical Trial

Subtenon Autologous Platelet-Rich Plasma in Inherited and Degenerative Retinal Diseases

Study acronym: RETINA-PRP
Active, Not Recruiting Phase 1/2
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Summary
his prospective, comparative pilot study investigates the safety and functional outcomes of subtenon autologous platelet-rich plasma (PRP) in patients with Retinitis Pigmentosa (RP) and Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP). Participants will receive three subtenon injections of autologous platelet-rich plasma (1.5 mL per injection) administered at two-month intervals (M0, M2, M4). The primary objective is to assess functional changes over a 6-month period, with a focus on visual field preservation, evaluated by the Field Preservation Deviation Index (FPDI) and Mean Deviation (MD), as well as best-corrected visual acuity (BCVA, LogMAR). Secondary outcomes include changes in 30-Hz flicker electroretinography (ERG) amplitude, structural retinal parameters on optical coherence tomography (OCT)-including central macular thickness and ellipsoid zone length-and ocular safety outcomes, such as intraocular pressure, local tolerability, and the occurrence of inflammatory or adverse events related to subtenon PRP administration.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2026-01-09; most recent amendment 2026-06-28.
Trial Details
NCT Number NCT07341919
Lead Sponsor Rubens Camargo Siqueira
Conditions Extensive Macular Atrophy With Pseudodrusen (EMAP), Retinitis Pigmentosa (RP)
Enrollment 30 participants
Start Date 2025-01-04
Primary Completion 2026-03-04 (estimated)
Study Completion 2027-01-04 (estimated)
Updated on ClinicalTrials.gov 2026-07-01