NCT05904028 Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
| NCT ID | NCT05904028 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jaeb Center for Health Research |
| Condition | Neovascular Age-related Macular Degeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-11-09 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2023-11-09 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Frequently Asked Questions
Who can join the NCT05904028 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Neovascular Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05904028 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT05904028 currently recruiting?
Yes, NCT05904028 is actively recruiting participants. Visit ClinicalTrials.gov or contact Jaeb Center for Health Research to inquire about joining.
Where is the NCT05904028 trial being conducted?
This trial is being conducted at Glendale, United States, Loma Linda, United States, Oakland, United States, Oakland, United States and 11 additional locations.
Who is sponsoring the NCT05904028 clinical trial?
NCT05904028 is sponsored by Jaeb Center for Health Research. The trial plans to enroll 600 participants.