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Subtenon Autologous Platelet-Rich Plasma in Inherited and Degenerative Retinal Diseases
Sponsor: Rubens Camargo Siqueira
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
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