A Randomized, Double-blind, Multicenter, Sham-controlled, Safety and Efficacy Study of Conbercept in Patients With mCNV (SHINY)

Kanghong Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Choroid Neovascularization Secondary to Degenerative Myopia

Treatments: Other: sham injection; Drug: conbercept, PRN; Drug: conbercept, Fixed

Study type: Interventional

Funder types: Industry

Identifiers

NCT01809223

KHSWKH902007

Details and patient eligibility

About

This study is design to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes compared to sham injection and durability of response observed in subjects with choroid neovascularization secondary to pathological myopia.

Enrollment: 176 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients give fully informed consent and are willing and able to comply with all study procedures.

2. In the study eye:

   • Myopia of equal to or greater than -6.00D,and axial length ≥26.5mm.
   • Diagnosis of active subfoveal, juxafoveal, or extrafoveal CNV secondary to high myopia.
   • Visual impairment due to CNV secondary to high myopia.
   • BCVA score ≥24 and ≤73 ETDRS letters (approximately 20/40~ 20/320 Snellen equivalent).
   • Ocular media of sufficient quality to obtain fundus and OCT images.

3. The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent)

Exclusion criteria

1. Current vitreous hemorrhage in either eye.
2. Intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye.
3. Active infectious ocular inflammation in either eye.
4. Fibrosis or atrophy involving the center of foveal in the study eye.
5. Any concurrent intraocular condition in the study eye that, in the opinion of investigator, could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition.
6. The lesion size ≥30 mm2 in the study eye.
7. Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results.
8. Uncontrolled glaucoma or cup/disk ratio > 0.8 in the study eye.
9. Aphakia (excluding artificial lens) in the study eye.
10. Serious amblyopia and amaurosis in the fellow eye.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 2 patient groups

conbercept treatment group

Experimental group

Description:

Subjects will receive conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 6 months, the investigator will decide whether repeat injections are needed base on the monthly assessment results.

Treatment:

Drug: conbercept, Fixed

Drug: conbercept, PRN

sham injection group

Sham Comparator group

Description:

Subjects will receive sham injections monthly for 3 months and will receive 0.5 mg/eye conbercept at month 4. The investigator will decide whether repeat injections are needed base on the monthly assessment results from month 5 to month 9.

Treatment:

Drug: conbercept, Fixed

Drug: conbercept, PRN

Other: sham injection