Conbercept in Choroidal Neovascularization Secondary to Uveitis

Uveitis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02934841
• Other study ID #: BQE-10
• Status: Not yet recruiting
• Phase: Phase 2
• First received: October 13, 2016
• Last updated: October 13, 2016
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: October 2016
• Source: Chongqing Medical University
• Contact: Shulin Liu
• Phone: +86 02389012010
• Email: shulinliu_cmu[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Chongqing City
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Neovascularization, Pathologic
• Uveitis

Intervention

Drug:
• Conbercept

• sham

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 12		Baseline, month 12	No
Secondary	Percentage of Participants Who Gained at Least 15/10/5 Letters in BCVA as Measured by ETDRS at month 6		Baseline, month 6	No
Secondary	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	No
Secondary	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	No
Secondary	Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) at every visit		12 months	No
Secondary	Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to month 3/6/12		Baseline, month 3, 6 and 12	No
Secondary	Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to month 12		Baseline, month 12	No
Secondary	Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to month 12		Baseline, month 12	No
Secondary	Mean Change in Area of Leakage assessed by FFA From Baseline at month 3\6\12		Baseline, month 3, 6 and 12	No
Secondary	Number of participants with adverse events	Compare of Number of participants with adverse events between the two groups to assess the safety of conbercept	12 months	Yes