Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

Symtomatic Macular Polypoidal Choroidal Vasculopathy Clinical Trial

Official title:

Intravitreal Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy (PCV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860858
• Other study ID #: 18265_CREC032/59BPs
• Status: Completed
• Phase: Phase 4
• Start date: December 30, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2018
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To evaluate the efficacy of intravitreal aflibercept injection on visual acuity in patients with symptomatic macular PCV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Symtomatic Macular Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Biological:
• Intravitreous aflibercept injection

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity (BCVA)		2 years