Conbercept in Choroidal Neovascularization Secondary to Uveitis

NCT ID: NCT02934841

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-11-30

Brief Summary

The investigators hypothesize that it is safe and effective to treat patients with choroidal neovascularisation (abnormal blood vessels growing under the retina) secondary to uveitis with Conbercept.

This will be a randomized, placebo-controlled trial. 20 patients will receive three injections of Conbercept into the affected eye (and repeated injections if required), and 20 patients will receive three sham injections requiring no needle stick, but making the patient unaware of whether or not he received active treatment.

Outcome of the two treatment groups will be compared after one year.

Detailed Description

Primary Outcome Measures: Mean change from baseline in best corrected visual acuity [ Time Frame: 12 months ]

Secondary Outcome Measures: Mean change from baseline in retinal thickness [ Time Frame: 12 months ]

Mean number of Conbercept injections required over 12 months [ Time Frame: 12 months ]

Ocular and systemic adverse events [ Time Frame: 12 months ]

Enrollment: 40

Intervention Details: Drug: Conbercept

20 patients will receive an intravitreal injections of conbercept 0.5 mg at baseline (visit 1; month 0) then a subsequent intravitreal injection at month 1 (visit 2) and month 2 (Visit 3). Patients will be reviewed every month thereafter for 12 months at which time it will be determined whether the patient requires retreatment with conbercept 0.5 mg based on measurements of visual acuity, Optical coherence tomography (OCT) findings, FFA and clinical appearance.

Conditions

Choroidal Neovascularization; Uveitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Conbercept

The patients are followed on a monthly basis until 12 months. Three intravitreal injections of conbercept at a dosage of 0.5 mg are initiated at inclusion (monthly) with reinjection every month only in case of CNV activity (PRN regimen) until 12 months.

Group Type: EXPERIMENTAL

Conbercept

Intervention Type: DRUG

sham

The patients are followed on a monthly basis until 12 months. Three intravitreal sham injections are initiated at inclusion (monthly) with reinjection every month only in case of CNV activity (PRN regimen) until 12 months.

Group Type: SHAM_COMPARATOR

sham

Intervention Type: DRUG

Interventions

Conbercept

Intervention Type: DRUG

sham

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient with uveitis (without signs of active uveitis) related CNV, whatever the cause, including multifocal choroiditis, punctate inner choroidopathy, ocular toxoplasmosis, serpiginous choroiditis, Birdshot chorioretinopathy or VKH syndrome, etc, with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography and/or OCT in the studied eye
• Total lesion area < 12 disc areas.
• Total area of CNV within the lesion must be > 50% of total lesion.
• Best corrected visual acuity of 20/40 to 20/320 in the study eye.
• Willing and able to give informed consent.

Exclusion Criteria

• Prior treatment in the study eye with, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy or other anti VEGF treatments,
• History of submacular surgery or other surgical intervention in the study eye, glaucoma filtration surgery, corneal transplant surgery,
• Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline,
• Extracapsular extraction of cataract with phacoemulsification within three months preceding baseline, or a history of post-operative complications within the last 12 months preceding baseline in the study eye (uveitis, cyclitis, etc.),
• History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication),
• Aphakia with absence of the posterior capsule in the study eye,
• Active intraocular inflammation (grade trace or above) in the study eye,
• Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis,
• Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye,
• Presence of a retinal pigment epithelial tear involving the macula in the study eye,
• Subfoveal fibrosis or atrophy in the study eye.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shulin Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Shulin Liu

Role: CONTACT

shulinliu_cmu@163.com

+86 02389012010

Other Identifiers

BQE-10

Identifier Type: -

Identifier Source: org_study_id