{ "data": { "asOf": "2026-10-30T22:24:35.261Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07348588", "title": "Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases", "scientificTitle": "Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases: A Prospective Comparative Pilot Study", "status": "active", "studyType": "interventional", "phase": [ "PHASE1", "PHASE2" ], "conditions": [ "Retinitis Pigmentosa (RP)", "Extensive Macular Atrophy With Pseudodrusen (EMAP)" ], "interventions": [ { "name": "Intravitreal Adalimumab", "type": "DRUG", "description": "Participants receive intravitreal injections of adalimumab 2 mg/0.05 mL at baseline (M0), month 2 (M2), and month 4 (M4)." } ], "sponsor": { "name": "Centro de Pesquisa Rubens Siqueira", "type": "OTHER" }, "locations": [ { "city": "São José do Rio Preto", "country": "Brazil", "facility": "Rubens Siqueira Research Center" } ], "outcomes": { "other": [], "primary": [ "Change in Field Preservation Deviation Index (FPDI)", "Change in Mean Deviation (MD)", "Change in Best-Corrected Visual Acuity (BCVA)" ], "secondary": [ "Change in Pattern Standard Deviation (PSD)", "Change in 30-Hz Flicker ERG Amplitude", "Change in Central Macular Thickness (CMT)", "Change in Ellipsoid Zone (EZ) Length" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\nAge ≥ 18 years.\n\n* Clinical diagnosis of retinitis pigmentosa (RP) or EMAP (Extensive Macular Atrophy with Pseudodrusen-like Appearance) confirmed by multimodal evaluation.\n* Best-corrected visual acuity (BCVA) ≥ counting fingers at 1 meter (approximately ≤ 1.9 logMAR) in the study eye.\n* Measurable visual field on iCare COMPASS (10-2 or 24-2) with acceptable reliability indices.\n* Clear ocular media adequate for safe intravitreal injection and high-quality OCT imaging.\n* Ability and willingness to provide written informed consent.\n* 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\\]).\n* 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).\n* Note: Absence of a measurable flicker ERG response does not exclude participation in the main study.\n\nExclusion Criteria:\n\n* Active ocular inflammation (anterior, intermediate, or posterior uveitis) or infectious ocular disease in the study eye.\n* Active choroidal neovascularization or other macular diseases unrelated to RP or EMAP.\n* Uncontrolled glaucoma (intraocular pressure \\> 21 mmHg despite therapy) or optic neuropathies not related to RP or EMAP.\n* Significant media opacity that may impair imaging quality or safe intravitreal injection.\n* Recent ocular interventions that may confound study outcomes, including:\n* Intravitreal therapy within 3 months prior to enrollment.\n* Periocular corticosteroid injection within 3 months prior to enrollment.\n* Major intraocular surgery within 3 months prior to enrollment.\n* Known hypersensitivity to adalimumab, povidone-iodine, local anesthetics, or any formulation components.\n* Coagulopathy or contraindications to ocular injections (platelet count \\< 100,000/µL or INR \\> 1.5 unless corrected).\n* Pregnancy or breastfeeding.\n* Women of childbearing potential unwilling to use effective contraception during the study period.\n* Uncontrolled systemic disease that increases risk or interferes with study participation or completion.\n* Participation in another interventional clinical trial within 3 months prior to enrollment.", "maximumAge": "80 Years", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 30 }, "startDate": "2025-07-10", "completionDate": "2027-08-01", "lastUpdated": "2026-10-27T00:00:00.000Z", 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