Symtomatic Macular Polypoidal Choroidal Vasculopathy
Conditions
Brief summary
Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular PCV.
Interventions
BIOLOGICALIntravitreous aflibercept injection
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or Female \>/= 18 years * Confirmed diagnosis of symptomatic macular PCV in the study eye defined by: - Active macular polypoidal lesions shown by ICGA and - Presence of serosanguinous maculopathy * BCVA letter score between 78-24 using ETDRS visual acuity chart measured at 4 meters
Exclusion criteria
* Previous treatment with systemic anti-VEGF drugs within 6 months prior to Baseline (e.g., sorafenib \[Nexavar®\], sunitinib \[Sutent®\], bevacizumab \[Avastin®\]) Study eye: * Active ocular inflammation or infection (ocular or periocular) * Uncontrolled intraocular hypertension or glaucoma (IOP\> 30 mmPIg) despite treatment with anti-glaucoma medication * Predominantly-scarred PCV lesions * Ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise VA or require medical or surgical intervention during the study period * Prior treatment with verteporfin PDT, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy * Prior treatment with any anti-VEGF compound or any investigational treatment * Treatment with intravitreal or subtenon corticosteroid injection or device implantation within 90 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity (BCVA) | 2 years |
Countries
Thailand
Outcome results
None listed