Active — Not RecruitingPhase 1/2

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

Brazil30 participantsStarted 2025-01-04

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Age ≥ 18 years. * Clinical diagnosis of retinitis pigmentosa (RP) or EMAP (Extensive Macular Atrophy with Pseudodrusen-like Appearance), confirmed by multimodal evaluation. * Best-corrected visual acuity (BCVA) ≥ counting fingers at 1 meter (approximately ≤ 1.9 logMAR) in the study eye. * Measurable visual field on iCare COMPASS (10-2 or 24-2) with acceptable reliability indices. * Clear ocular media adequate for safe intravitreal injection and high-quality optical coherence tomography (OCT) imaging. * Ability and willingness to provide written informed consent. * Ability to comply with scheduled study visits, including: * Baseline (M0) * Day 7-14 after injections * Month 2 (M2), Day 7-14 * Month 4 (M4), Day 7-14 * Month 6 (M6) * For ERG subset only: o Presence of a recordable baseline 30-Hz flicker electroretinogram (ERG) response, defined as a signal-to-noise ratio ≥ 3:1 and amplitude ≥ 3.0 μV. * Note: Absence of a measurable flicker ERG response does not exclude participation in the main study. Exclusion Criteria * Active ocular inflammation (anterior, intermediate, or posterior uveitis) or active infectious ocular disease in the study eye. * Active choroidal neovascularization or other macular diseases unrelated to RP or EMAP. * Uncontrolled glaucoma (intraocular pressure \> 21 mmHg despite therapy) or optic neuropathies not related to RP or EMAP. * Significant media opacity that may impair imaging quality or compromise the safety of …

What they're measuring

Change in Field Preservation Deviation Index (FPDI)

Timeframe: Baseline to Month 6

. Change in Mean Deviation (MD)

Timeframe: Baseline to Month 6

. Change in Best-Corrected Visual Acuity (BCVA)

Timeframe: Baseline to Month 6

Trial details

NCT IDNCT07341919

SponsorRubens Camargo Siqueira

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-04

View on ClinicalTrials.gov More Extensive Macular Atrophy With Pseudodrusen (EMAP) trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.