Polypoidal Choroidal Vasculopathy, Polypoidal Choroidal Vasculopathy (PCV)
Conditions
Keywords
PCV, Polypoidal Choroidal Vasculopathy, PALLAS, Aflibercept 8 mg
Brief summary
The purpose of this study is to evaluate the efficacy and safety of the aflibercept 8 mg used in a personalized regimen, with flexible loading dose and treatment intervals from 8 to 24 weeks in eyes with treatment-naive PCV.
Interventions
DRUGaflibercept 8 mg
The first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively.
Sponsors
Yeungnam University College of Medicine
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent must be obtained prior to participation in the study. 2. Male or female patients ≥ 19 years of age at screening 3. Presence of active polypoidal lesions in the macular as shown by ICGA and presence of serosanguinous maculopathy (exudative or hemorrhagic features involving the macula on floor fundus photography, FA and SD-OCT AND presence of IRF or SRF that affects the central subfield as seen by SD-OCT 4. Best-corrected visual acuity (BCVA) score between 83 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye)
Exclusion criteria
1. Ocular conditions/disorders at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye) 2. A history of any evidence of type 2 or type 3 neovascularization, myopic choroidal neovascularization, or other ocular disorders 3. Total area of subretinal hemorrhage larger than 9DA or comprising ≥ 50% of the lesion area or presence of vitreous hemorrhage in study eye 4. Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye) 5. Uncontrolled glaucoma defined as intraocular pressure (IOP) \> 25 mmHg on medication, or according to investigator's judgment, at screening or baseline (study eye) 6. Ocular treatments: any anti-VEGF drugs, intraocular or periocular steroids, macular laser photocoagulation or PDT, previous ocular surgery except cataract surgery (study eye) 7. Stroke or myocardial infarction during the 6-month period prior to baseline 8. Systemic anti-VEGF therapy at any time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 | Week 96 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Last injection interval at week 96 | Week 96 | — |
| Best corrected visual acuity (BCVA) at weet 96 | Week 96 | Measurement with the Early Treatment Diabetic Retinopathy Study (ETDRS) letters score |
| Central retinal thickness and choroidal thickness at week 96 | Week 96 | Average retinal thickness at the central 1 mm diameter |
| umber of participants with treatment-related adverse events | Week 96 | Slit lamp examination and fundoscopy |
Countries
South Korea
Contacts
CONTACTSohee Shin
Outcome results
None listed