drugset / Trial / NCT07341919

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

NCT07341919

Phase 1/2 Active not recruiting 30 enrolled Rubens Camargo Siqueira
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-01-04
Primary completion
2026-03-04
Completion
2027-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Platelet Rich Plasma Other / unclassified 1.5 ml Other

Indications