NCT07341919Active, not recruitingPhase 1/2
Subtenon Autologous Platelet-Rich Plasma in Inherited and Degenerative Retinal Diseases
Subtenon Autologous Platelet-Rich Plasma in Inherited and Degenerative Retinal Diseases: A Prospective Comparative Pilot Study
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Dec 2025
- Start date
- 4 Jan 2025
- Primary completion date
- 4 Mar 2026
- Lead sponsor
- Rubens Camargo Siqueira
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT07341919
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 4 Jan 2025 to the primary completion date, 4 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Uncontrolled glaucoma (intraocular pressure \> 21 mmHg despite therapy) or optic neuropathies not related to RP or EMAP.
- Recent ocular interventions that may confound study outcomes, including:
- Intravitreal therapy within 3 months prior to enrollment.
- Periocular corticosteroid injection within 3 months prior to enrollment.
- Major intraocular surgery within 3 months prior to enrollment.
- Participation in another interventional clinical trial within 3 months prior to enrollment.
Other illness
- 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.
- Known hypersensitivity to adalimumab, povidone-iodine, local anesthetics, or any component of the study formulations.
- Uncontrolled systemic disease that, in the investigator's judgment, increases risk or interferes with study participation or completion.
Lab values
- Coagulopathy or contraindications to ocular injections, including:
- Platelet count \< 100,000/μL, or
- INR \> 1.5 unless adequately corrected.
Other
- Significant media opacity that may impair imaging quality or compromise the safety of intravitreal injection.
- Pregnancy or breastfeeding.
- Women of childbearing potential unwilling to use effective contraception during the study period.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Especializado Retina e Vítreo Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.