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Retinal Vein OcclusionPhase 2FALCONNCT01809236

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

A Phase 2 study testing Conbercept in people with Retinal Vein Occlusion, run by Chengdu Kanghong Biotech Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinal Vein Occlusion
What is being tested?
Conbercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesChina
Study dates
May 2012to Mar 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability and willingness to provide signed Informed Consent Form.
  • Age ≥ 18, both male and female。
  • 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.

Who cannot join

  • Brisk afferent pupillary defect.
  • 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.
  • 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.
  • Any active infection involving the ocular including blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis in either eye.
  • Any inflammatory cells detected in the anterior chamber and/or vitreous in the study eye.
  • 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.
Show all 11Show fewer
  • Neovascular change in the study eye and/or neovascularization of the iris or neovascular glaucoma in study eye at baseline.
  • 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.
  • Patients diagnosed with systemic immune diseases and any uncontrolled clinical disease.
  • Pregnant or nursing women.
  • Patients need to exclude in the opinion of investigator.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Tongren hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100730

  • The Affiliated Eye Hospital of WMC

    Wenzhou, Zhejiang, 325027

Other trials in China

About this study

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)

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.

Being tested
Conbercept
Medical subject headings
Retinal Vein Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ConberceptBiological

    intravitreal injection of 0.5 mg Conbercept

Study groups in NCT01809236
Study groupRoleWhat they receive
0.5 mg ConberceptExperimentalpatients 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.
Receives: Biological: Conbercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline in BCVA

    Measured: 3-month

Secondary outcomes (5)

  1. Mean change from baseline in BCVA

    Measured: baseline to 9-month

  2. Mean change from baseline in central retinal thickness

    Measured: baseline to 9-month

  3. Mean injection times

    Measured: baseline to 9-month

  4. Mean change from baseline in Macular edema volume and other anatomical character in the study eye

    Measured: baseline to 9-month

  5. Rate of adverse event

    Measured: 3-month and 9-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2013 (estimated)
  2. Study startMay 2012
  3. Primary completionNov 2013
  4. Study completionMar 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01809236
Sponsor's protocol ID
KHSWKH902008
Acronym
FALCON
Status last verified
Mar 2014
First submitted
11 Mar 2013
Last updated
27 Mar 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Conbercept in people with Retinal Vein Occlusion, run by Chengdu Kanghong Biotech Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in BCVA (time frame: 3-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01809236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.

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