Interval of Disease Inactivity After Complete Polypoidal Regression in PCV Receiving Aflibercept

Sponsor
Chiang Mai University
Study ID
NCT04707027
Status
Unknown

Conditions

  • Polypoidal Choroidal Vasculopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept Injection (2 mg/0.05 ml) — DRUG
    Intravitreal aflibercept injections (treat and extend regimen)
  • Defer treatment — OTHER
    Follow up with fundus photo and OCT every 4 weeks

Study Details

Polypoidal choroidal vasculopathy (PCV), a subtype of neovascular age-related macular degeneration (NV AMD), is an important cause of central visual loss, especially among Asian and African descendants. PCV is characterized by the presence of hyperfluorescent polypoidal lesions, with or without branching vascular network, identified on indocyanine green angiography (ICGA), currently the gold standard for PCV diagnosis. In addition to visual improvement from baseline, polypoidal regression or complete disappearance of polypoidal lesions on ICGA has been considered an important treatment outcome in large PCV trials including the PLANET1 and EVEREST II2 studies. Rate of polypoidal regression following intravitreous aflibercept monotherapy was 33% in the PLANET study1 year 2 and ranged between 55% to 78% in other Asian cohorts.3-4 Recently, our previous investigation5 on the timing of polypoidal regression following a fixed-dosing aflibercept monotherapy (3 initial monthly injections, then q 8 weeks until 1 year) in 40 Thai PCV eyes suggested that, among 22 eyes (55%) with polypoidal regression at 1 year, a majority of them showed complete polypoidal regression before 6 months (median duration of complete regression: 3 months (IQR, 2 months to 6 months). However, due to the fixed-dosing regimen used in previous study, there are limited data on how often polypoidal lesions remain regressed on ICGA when the treatment is deferred in eyes with polypoidal regression, nor what changes might be seen subsequently on OCT when treatment is deferred in this situation. Therefore, this study aims to determine the changes seen on OCT subsequent to complete regression of polypoidal lesions on ICGA in PCV eyes following intravitreous aflibercept treatment. Results from this study may provide some insights on longer-term PCV management

Key Dates

Start date
Nov 1, 2020
Status verified
Jan 2021
Primary completion
Nov 30, 2022
Completion
Nov 30, 2023

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Sham Comparator: complete polypoidal regression arm
    follow up monthly with color fundus photography and OCT at each visit
  • Active Comparator: incomplete polypoidal regression arm
    continue treatment with aflibercept injection (treat and extend regimen)

Primary Outcome Measure

Interval of disease activity on color fundus photography or optical coherence tomography [ Time Frame: 1 to 24 months ]

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