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Active Not Recruiting
NCT05904028
Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
Conditions: Neovascular Age-related Macular Degeneration
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 603
Sponsor: Jaeb Center for Health Research
Location: Kent W. Small, MD, AMC Glendale California
Summary
Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.
Eligibility Criteria
Key Inclusion Criteria:
* Age ≥ 50 years
* Have the capacity to consent on his/her own behalf
* Able to successfully and independently complete at least one self-scanning session on the Home OCT device located at the enrolling clinical site
* Willing to perform once daily Home OCT monitoring tests for 2 years without significant interruption (such as travel of more than 14 days)
* Best corrected E-ETDRS visual acuity ≥24 ETDRS letters (approximately 20/320 or better (Snellen))
* Previously untreated, active MNV lesion (i.e., any intraretinal or subretinal fluid within the center 3 mm diameter circle on OCT) secondary to age-related macular degeneration
* ≥ 1 intermediate drusen (≥ 63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye
Key Exclusion Criteria for Study Eye:
* Previous treatment for MNV (intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent, or any other AMD therapy)
* Prior treatment with intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent or with macular laser for any indication
* Treatment with intravitreal corticosteroids within the last 6 months
* A condition that, in the opinion of the investigator, would preclude participation in the study or ability to complete daily Home OCT scans for 2 years (e.g., unstable medical status that may preclude successful completion of follow-up, dementia, Alzheimer's disease, uncontrollable tremors)
* MNV due to other causes, such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia
Source: ClinicalTrials.gov (NCT05904028). StuddyBuddy aggregates publicly available trial information.