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ACTIVE NOT RECRUITING
NCT07341919
PHASE1/PHASE2

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

Sponsor: Rubens Camargo Siqueira

View on ClinicalTrials.gov

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.

Official title: Subtenon Autologous Platelet-Rich Plasma in Inherited and Degenerative Retinal Diseases: A Prospective Comparative Pilot Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-01-04

Completion Date

2027-01-04

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

Subtenon Injection of Autologous Platelet-Rich Plasma

Biological: Subtenon Autologous Platelet-Rich Plasma Participants receive subtenon injections of autologous platelet-rich plasma (PRP), 1.5 mL per injection, administered at baseline (M0), month 2 (M2), and month 4 (M4).

Locations (1)

Centro Especializado Retina e Vítreo

São José do Rio Preto, São Paulo, Brazil