A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neova… (NCT06795048) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
United States274 participantsStarted 2025-03-14
Plain-language summary
This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.
Who can participate
Age range50 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.
Inclusion Criteria:
* Overtly healthy as determined by medical evaluation that includes medical history and physical examination
* Agreement to adhere to the contraception requirements described in the protocol
Ocular Inclusion Criteria for Study Eye:
* Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical coherence tomography (OCT)
* BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study \[ETDRS\] protocol and addressed at the initial testing distance of 4 meters on Day 1)
* Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
Exclusion Criteria:
Ocular Exclusion Criteria for Study Eye:
* MNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
* Retinal pigment epithelial tear involving the macula on Day 1
* Current vitreous hemorrhage on Day 1
* Prior periocular pharmacological or IVT treatment (including faricimab, anti-vascular endothelial growth factor \[VEGF\], or complement inhibitor medication) for other retinal diseases
Ocular Exclusion Criteria for Fellow (Non-Study) Eye:
* Participants who have a nonfunctionin…
What they're measuring
1
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52
Timeframe: Baseline and average of Weeks 44, 48, and 52