Conbercept in Choroidal Neovascularization Secondary to Uveitis

NCT02934841 | Unknown Phase 2 DMC

• 1 other identifier: BQE-10
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Choroidal Neovascularization; Uveitis

Outcome Measures

Primary Outcomes (1)

• Mean Change in Best Corrected Visual Acuity (BCVA)Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)at every visit

  Compare of mean BCVA at every visit between the two groups to assess the efficacy of conbercept.

  From Baseline to month 12

Secondary Outcomes (10)

• Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 12

  Baseline, month 12

• Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 6

  Baseline, month 6

• Percentage of Participants Who Lost at Least 15/10/5 Letters in BCVA Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) at month 6

  Baseline, month 6

• Percentage of Participants Who Lost at Least 15/10/5 Letters in BCVA Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) at month 12

  Baseline, month 12

• Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) at every visit

  12 months

Study Arms (2)

Conbercept

EXPERIMENTAL

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.

Drug: Conbercept

sham

SHAM COMPARATOR

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.

Drug: sham

Interventions

Conbercept DRUG

Conbercept

sham DRUG

sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing Medical University: lead

MeSH Terms

Conditions

Choroidal Neovascularization; Uveitis

Interventions

KH902 fusion protein; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shulin Liu

CONTACT

+86 02389012010; shulinliu_cmu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 17, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 17, 2016

Record last verified: 2016-10