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

NCT04707027 | Unknown

• 1 other identifier: OPT-2563-07160
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Interval of disease activity on color fundus photography or optical coherence tomography

  * Disease inactivity on color fundus photography is defined as an absence of new retinal or subretinal or sub-RPE hemorrhage on color fundus photography compared with baseline * Disease inactivity on OCT is defined as an absence of intraretinal thickening or CME or subretinal fluid or PED or enlarging PED on OCT

  1 to 24 months

Other Outcomes (2)

• Systemic adverse event

  1 to 24 months from baseline

• Ocular adverse event

  1 to 24 months from baseline

Study Arms (2)

complete polypoidal regression arm

SHAM COMPARATOR

follow up monthly with color fundus photography and OCT at each visit

Other: Defer treatment

incomplete polypoidal regression arm

ACTIVE COMPARATOR

continue treatment with aflibercept injection (treat and extend regimen)

Drug: Aflibercept Injection (2 mg/0.05 ml)

Interventions

Aflibercept Injection (2 mg/0.05 ml) DRUG

Intravitreal aflibercept injections (treat and extend regimen)

Also known as: Eylea

incomplete polypoidal regression arm

Defer treatment OTHER

Follow up with fundus photo and OCT every 4 weeks

complete polypoidal regression arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of ≥18 years
• Diagnosis of treatment-naïve PCV in either eye
• PCV is defined according to the following criteria Presence of focal subretinal ICGA hyperfluorescence within the first 6 minutes, plus one of the followings; 1) subretinal orange nodule corresponds to hyperfluorescent nodule on ICGA, 2) massive submacular hemorrhage of 4 disc area or larger, 3) nodular appearance on stereoscopic viewing, 4) pulsatile polypoidal lesion, 5) abnormal vascular channel supplying the polypoidal lesion, 6) hypofluorescent halo around the nodule6
• If any participant presents with bilateral PCV in which both eyes are eligible for the study, the eye with worse vision will be chosen as the study eye

You may not qualify if:

• Presence of co-existing vision threatening conditions in the study eye, e.g., diabetic retinopathy, or retinal vascular occlusion
• Presence of ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or any of the excipients in aflibercept
• Inability to obtain good quality imaging due to ocular media abnormalities
• Contraindicate for FFA or ICGA due to the following conditions:
• Allergic to fluorescein or indocyanine green dye
• Allergic to iodine or seafood
• Impaired kidney or liver functions
• Not able to follow up according to the study protocol

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Voraporn Chaikitmongkol

Chiang Mai, 50200, Thailand

RECRUITING

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2023
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)