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Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy

NCT03244657 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-08-09

No results posted yet for this study

Summary

To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects.

Conditions

  • Polypoid Choroidal Vasculopathy (PCV)

Interventions

DRUG

conbercept ophthalmic injection （0.5mg）

The target eye receives intravitreal injection of 0.5mg conbercept ophthalmic injection once every 12 weeks; if a subject meets "additional drug administration criteria" within 12 weeks between treatments, the subject can receive additional injection treatment

DRUG

conbercept ophthalmic injection （0.5mg）

In principle, the first administration time of the target eye uses the time determined by the assessment at end of STAR study; later, based on "treatment-extension drug administration criteria", an investigator determines next visit time/treatment interval according to assessment result at each visit.When a subject's visit/treatment interval extends to 12 weeks, an additional safety visit can be arranged if an investigator considers that there is suspicious active lesion; if assessment result at the safety visit meets "additional drug administration criteria", additional injection treatment can be given.

Sponsors & Collaborators

  • Chengdu Kanghong Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2019-10-31
Completion
2020-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03244657 on ClinicalTrials.gov