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

NCT04707027 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-01-15

No results posted yet for this study

Summary

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

Conditions

  • Polypoidal Choroidal Vasculopathy

Interventions

DRUG

Aflibercept Injection (2 mg/0.05 ml)

Intravitreal aflibercept injections (treat and extend regimen)

OTHER

Defer treatment

Follow up with fundus photo and OCT every 4 weeks

Sponsors & Collaborators

  • Chiang Mai University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-11-30
Completion
2023-11-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04707027 on ClinicalTrials.gov