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

NCT07341919 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

  • Extensive Macular Atrophy With Pseudodrusen (EMAP)
  • Retinitis Pigmentosa (RP)

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).

Sponsors & Collaborators

  • Rubens Camargo Siqueira

    lead OTHER

Principal Investigators

  • Rubens C Siqueira, MD,PhD · Rubens Siqueira Research Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07341919 on ClinicalTrials.gov