Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases

This prospective, comparative pilot study investigates the safety and functional outcomes of intravitreal adalimumab (ADA) in patients with Retinitis Pigmentosa (RP) and Extensive Macular Atrophy with Pseudodrusen-like Appearance (EMAP). Participants will receive three intravitreal injections of adalimumab (2 mg/0.05 mL) at two-month intervals (M0, M2, M4). The primary objective is to assess functional changes after 6 months, focusing on visual-field preservation (Field Preservation Deviation Index - FPDI, Mean Deviation - MD) and best-corrected visual acuity (LogMAR). Secondary outcomes include alterations in 30-Hz flicker ERG amplitude, OCT parameters (central macular thickness and ellipsoid zone length), and ocular safety measures such as intraocular pressure and inflammatory response.

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 OCT imaging. * Ability and willingness to provide written informed consent. * Ability to comply with scheduled study visits (Baseline \[M0\], Day 7-14 after injections, Month 2 \[M2\], Day 7-14, Month 4 \[M4\], Day 7-14, and Month 6 \[M6\]). * For ERG subset only: presence of a recordable baseline 30-Hz flicker ERG response (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 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 safe intravitreal injection. * 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. * Known hypersensitivity to adalimumab, povidone-iodine, local anesthetics, or any formulation components. * Coagulopathy or contraindications to ocular injections (platelet count \< 100,000/µL or INR \> 1.5 unless corrected). * Pregnancy or breastfeeding. * Women of childbearing potential unwilling to use effective contraception during the study period. * Uncontrolled systemic disease that increases risk or interferes with study participation or completion. * Participation in another interventional clinical trial within 3 months prior to enrollment.