NCT04380974

Efficacy and Safety of Two Regimens of Anti-VEGF Therapy in Chinese Patients With Polypoidal Choroidal Vasculopathy

A Random, Open-label Multicenter, Phase IV Study Assessing the Efficacy and Safety of Two Regimens of Anti-VEGF Therapy in Chinese Patients With Polypoidal Choroidal Vasculopathy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Xiaodong Sun · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the efficacy and safety of two different regimens of anti-VEGF Therapy (OCTA plus OCT guided 3+PRN vs. OCT guided 3+PRN) in Chinese patients with PCV. This study is to provide long-term safety data in the treatment of Chinese patients with PCV.

Conditions

• Polypoidal Choroidal Vasculopathy

Interventions

Type	Name	Description
PROCEDURE	OCTA plus OCT guided 3+PRN regimen	For the OCTA plus OCT guided 3+PRN regimen, we recorded patients' data after retreatment by 3 monthly intravitreal injections of anti-VEGF drug. Subsequent reinjections were given as needed according to the changes in patients' visual acuity, activity of PCV lesions shown by OCTA and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this group underwent an examination, including ETDRS visual acuity, fundus photography, OCTA and OCT. In case of BVN increased or polypoidal lesion progressed on OCTA scans, persistent subfoveal or perifoveal fluid, macular intraretinal edema on OCT scans, or visual loss of \>5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later.
PROCEDURE	OCT guided 3+PRN regimen	For the OCT guided 3+PRN group, we recorded patients'data after retreatment by 3 monthly intravitreal injections of Anti-VEGF drugs. Subsequent reinjections were given as needed according to the changes in patients'visual acuity and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this group underwent an examination, including ETDRS visual acuity, fundus photography, and OCT. In case of persistent subfoveal or perifoveal fluid, macular intraretinal edema, visual loss of \>5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later.
DRUG	Anti-VEGF drug	Conbercept or other anti-VEGF drugs

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-10-01
• Completion: 2022-09-01
• First posted: 2020-05-08
• Last updated: 2020-05-08

Locations

1 site across 1 country: China