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Efficacy and Safety of Conbercept in Macular Edema Secondary to Retinal Vein Occlusion (FALCON)

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ClinicalTrials.gov Identifier: NCT01809236
Recruitment Status : Unknown
Verified March 2014 by Chengdu Kanghong Biotech Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : March 12, 2013
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co., Ltd.

Brief Summary:
This is a Phase II, single arm, open label clinical trial. 60 RVO patients (including 30 BRVO and 30 CRVO, respectively) are enrolled in the study. The study included a fixed treatment period (3 months) and a PRN period (6 months). In the fixed treatment period patients will receive 3 consecutive monthly intravitreal of 0.5 mg Conbercept. In the PRN period, patients are monthly visited and retreatment will be needed according to the retreatment criteria pre-specified.

Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion Biological: Conbercept Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single Arm Clinical Study of Intravitreal Injection of Conbercept in Patients With Maculae Edema Secondary to Retinal Vein Occlusion (the FALCON Study)
Study Start Date : May 2012
Actual Primary Completion Date : November 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: 0.5 mg Conbercept
patients will receive monthly intravitreal injections of Conbercept to month 3 (total 3 times) and then on an as needed (PRN) dosing schedule based on the pre-specified retreatment criteria till to month 9.
Biological: Conbercept
intravitreal injection of 0.5 mg Conbercept




Primary Outcome Measures :
  1. Mean change from baseline in BCVA [ Time Frame: 3-month ]

Secondary Outcome Measures :
  1. Mean change from baseline in BCVA [ Time Frame: baseline to 9-month ]
  2. Mean change from baseline in central retinal thickness [ Time Frame: baseline to 9-month ]
  3. Mean injection times [ Time Frame: baseline to 9-month ]
  4. Mean change from baseline in Macular edema volume and other anatomical character in the study eye [ Time Frame: baseline to 9-month ]
  5. Rate of adverse event [ Time Frame: 3-month and 9-month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability and willingness to provide signed Informed Consent Form.
  2. Age ≥ 18, both male and female。
  3. Ocular Inclusion Criterion (Study Eye):

    • Diagnosis of Foveal center-involved macular edema due to RVO (both CRVO and BRVO) within 6 months.
    • Best corrected visual acuity (BCVA) letter score in the study eye of ≤ 73(Snellen equivalents 20/40).
    • Central retinal thickness by OCT in the study eye ≥ 320 μm.

Exclusion Criteria:

  1. Brisk afferent pupillary defect.
  2. History of any anti-VEGF treatment in the study and/or system within 6 months before enrollment, and/or in the fellow eye within 3 month.
  3. History of intraocular and/or peri-ocular corticosteroid use in the study eye within 3 months, and/or history of use steroids systemic (p.o., i.m., i.v.) within 1 month.
  4. Any active infection involving the ocular including blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis in either eye.
  5. Any inflammatory cells detected in the anterior chamber and/or vitreous in the study eye.
  6. Presence of non-RVO disease, in the opinion of the investigator, might cause macular edema, such as AMD (wet or dry), diabetes retinopathy, uveitis etc.
  7. Neovascular change in the study eye and/or neovascularization of the iris or neovascular glaucoma in study eye at baseline.
  8. Patients with substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by equal or more than 3 lines or medicine or surgery treatment are needed in the study eye within 4 months.
  9. Patients diagnosed with systemic immune diseases and any uncontrolled clinical disease.
  10. Pregnant or nursing women.
  11. Patients need to exclude in the opinion of investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809236


Locations
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China, Beijing
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, Beijing, China, 100730
China, Zhejiang
The Affiliated Eye Hospital of WMC
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Chengdu Kanghong Biotech Co., Ltd.

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Responsible Party: Chengdu Kanghong Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01809236     History of Changes
Other Study ID Numbers: KHSWKH902008
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases