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

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• Coagulopathy or contraindications to ocular injections, including:
  • Platelet count < 100,000/μL, or
  • INR > 1.5 unless adequately corrected.

Egyéb

• 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.

• 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.