An Open Label-study to Compare the Efficacy of Aflibercept Monotherapy for Polypoidal Choroidal Vasculopathy

Sponsor
Singapore National Eye Centre
Study ID
NCT03117634
Phase
PHASE4
Status
Completed

Conditions

  • Age Related Macular Degeneration
  • Polypoidal Choroidal Vasculopathy

Eligibility Criteria

Sex
ALL
Age
45 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Polypoidal choroidal neovasculopathy (PCV) is a subtype of wet age related macula degeneration (AMD) occuring more commonly in the Asian population. Besides the phenotypic differences, PCV is thought to have a lesser response to anti VEGF therapy which is the mainstay of treatment for other typical wet AMD. Recent trial data suggest that a combination with photodynamic therapy may help in the visual and anatomical outcome of PCV, and emerging evidence shows favourable outcomes the newer anti VEGF agent, aflibercept 2mg monotherapy. These trials however, have assessed aflibercept in a strict 2mg every 8 weekly regime. In the clinical setting, a significant an unmet need in the management of PCV is a tailored treatment regime. Here we propose a treatment regimen based on disease activity for PCV with aflibercept mono therapy. A limitation of the 2q8 regime is that it is fixed and does not vary regardless of polyp closure or anatomical outcome at the first time point of assessment (month 3). We hypothesize that after the initial 3 monthly injections of aflibercept, about 50% of PCV will close and become quiescent, and in the remaining 50%, a further 3 monthly injections will increase overall polyp closure rate. After a loadings phase of either 3 or 6 months, all eyes will start on a treat and extend regime (T\&E), with a minimum period of 8 weeks and a maximum of 12 weeks between treatments with 2 week increments if PCV remains quiescent. The proposed study aims to evaluate the efficacy of a modified treat and extend regime based on disease activity with aflibercept monotherapy for PCV.

Key Dates

Start date
Dec 1, 2017
Status verified
Aug 2021
Primary completion
Jun 30, 2020
Completion
Jan 31, 2021

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fixed dosing group (2Q8)
    Fixed Dosing with Aflibercept 2mg will be administered at a fixed regime at 8 week intervals through to week 52.
  • Experimental: Treat and Extend group (T&E)
    Reassessment at week 12 (month 3) by repeat examination for disease activity by OCT and indocyanine green angiography (ICGA). Subsequent treatment regime of Treat and Extend with Aflibercept 2mg will depend on disease activity at this point.

Primary Outcome Measure

Mean Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: From Baseline to Week 52 ]

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