Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

D
Denis Jusufbegovic, MD

Primary Investigator

Recruiting
50 years - 100 years
All
Phase N/A
3 participants needed
2 Locations

Brief description of study

What is the purpose of this study?
The main objective of this study is to determine if Home OCT-guided treatment results in 1) better visual acuity outcomes and/or 2) fewer number of injections over 104 weeks compared with treat and extend (T&E) dosing for nAMD.
 

Detailed description of study

What will happen during the study?
Upon completion of baseline testing procedures, eligible study eyes will enter the run-in phase and be given an injection of faricimab. The participant will be provided with a post-injection instruction sheet and will be reminded that the site will follow-up regarding eligibility for the randomization phase. The Notal Vision Monitoring Center must confirm adequate scan quality from the study eye prior to randomization. Once Notal Vision Monitoring Center confirms acceptable scans, randomization can be completed. The participant does not need to be present in the office for randomization. Randomization of eligible study eyes must occur within 10 days of the baseline visit. Prior to randomization, the site must call the participant to confirm they are still willing to participate and agree to follow the daily Home OCT scan requirement if randomized to the Home OCT group. Sites will also confirm the participant's understanding of the trial, willingness to accept the assigned treatment group, and commitment to the follow-up schedule, and compliance with device use.

Procedures at the baseline visit include eligibility assessment, vision testing, ocular examination, various imaging, and test session on the in-office Home OCT device. Eligible study eyes will enter the run-in phase and receive a baseline intravitreal faricimab injection. Participants must meet criteria for successful scanning as confirmed by Notal Vision for eligibility into the randomization phase. Eyes eligible for the randomization phase will be randomly assigned 1:1 into one of two groups to guide follow-up treatment: (1) Treat and Extend or (2) Home OCT-guided treatment.

Eyes receiving an initial faricimab injection that are not eligible for the randomization phase will have a final closeout safety visit 1 month after injection. For eyes in the randomization phase, follow-up for treatment group comparisons of vision and imaging outcomes will occur at 52- and 104-week visits. Additional visits will occur every 4-18 weeks in the T&E group. Participants assigned to the Home OCT group will self-scan daily using the Home OCT device and will only return for a visit if fluid passing the threshold for an office visit is seen on Home OCT. Follow-up visit procedures include vision testing, ocular exam, and various imaging. The primary outcomes are a comparison of mean change in visual acuity and number of injections from baseline to 104 weeks between the Home OCT vs. T&E groups (study eye only).
 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Neovascular Age-related Macular Degeneration, AMD
  • Age: 50 years - 100 years
  • Gender: All

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 macular neovascularization (MNV) lesion (i.e., any intraretinal or subretinal fluid on OCT) secondary to age-related macular degeneration
  •   MNV or sequelae of the MNV (i.e., pigment epithelium detachment, subretinal or sub-RPE hemorrhage, or subretinal, sub-RPE or intraretinal fluid) involving the foveal center
  •   ≥ 1 intermediate drusen (>63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye

 
Exclusion criteria
  •     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
  •   Any condition that may preclude adequate imaging of the macula (e.g., dense cataract or other media opacity, severe ptosis)
  •   MNV due to other causes, such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia


 

Updated on 21 Apr 2025. Study ID: OPTH-JAEB-PROTOCOL-AO, 23167

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