Trials / NCT07341919
Subtenon Autologous Platelet-Rich Plasma in Inherited and Degenerative Retinal Diseases
Underway, not enrolling Phase 1 / Phase 2 Drug / neuroprotection
- Sponsor
- Rubens Camargo Siqueira
- Treatment
- Subtenon Injection of Autologous Platelet-Rich Plasma
- Gene
- Not stated
- Conditions
- Extensive Macular Atrophy With Pseudodrusen (EMAP), Retinitis Pigmentosa (RP)
- Ages
- 18 Years to 80 Years
- Enrollment
- 30 participants
- Started
- 2025-01-04
- Main results expected
- 2026-03-04
- Results posted
- Not yet
- Record last updated
- 2026-07-01
What the study is testing
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.
Where it runs
Brazil (1)
- Centro Especializado Retina e Vítreo, São José do Rio Preto, São Paulo