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Status unknownNCT01809223SHINYUpdated Jun 4, 2014

A Randomized, Double-blind, Multicenter, Sham-controlled, Safety and Efficacy Study of Conbercept in Patients With mCNV

A Phase 3 interventional study of conbercept, Fixed and conbercept, PRN in Choroid Neovascularization Secondary to Degenerative Myopia, sponsored by Chengdu Kanghong Biotech Co., Ltd.. Status unknown at 13 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-04.

Sponsored by Chengdu Kanghong Biotech Co., Ltd. · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
176
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is design to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes compared to sham injection and durability of response observed in subjects with choroid neovascularization secondary to pathological myopia.

02

Conditions studied

  • Choroid Neovascularization Secondary to Degenerative Myopia
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 176 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Chengdu Kanghong Biotech Co., Ltd. is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients give fully informed consent and are willing and able to comply with all study procedures.

  2. In the study eye:

    • Myopia of equal to or greater than -6.00D,and axial length ≥26.5mm.
    • Diagnosis of active subfoveal, juxafoveal, or extrafoveal CNV secondary to high myopia.
    • Visual impairment due to CNV secondary to high myopia.
    • BCVA score ≥24 and ≤73 ETDRS letters (approximately 20/40\~ 20/320 Snellen equivalent).
    • Ocular media of sufficient quality to obtain fundus and OCT images.
  3. The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent)

Exclusion criteria

Exclusion Criteria:

  1. Current vitreous hemorrhage in either eye.
  2. Intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye.
  3. Active infectious ocular inflammation in either eye.
  4. Fibrosis or atrophy involving the center of foveal in the study eye.
  5. Any concurrent intraocular condition in the study eye that, in the opinion of investigator, could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition.
  6. The lesion size ≥30 mm2 in the study eye.
  7. Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results.
  8. Uncontrolled glaucoma or cup/disk ratio > 0.8 in the study eye.
  9. Aphakia (excluding artificial lens) in the study eye.
  10. Serious amblyopia and amaurosis in the fellow eye.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
176 participants (estimated)

Study arms

  • Experimental
    conbercept treatment group

    Subjects will receive conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 6 months, the investigator will decide whether repeat injections are needed base on the monthly assessment results.

    Drug: conbercept, Fixed · Drug: conbercept, PRN

  • Sham comparator
    sham injection group

    Subjects will receive sham injections monthly for 3 months and will receive 0.5 mg/eye conbercept at month 4. The investigator will decide whether repeat injections are needed base on the monthly assessment results from month 5 to month 9.

    Drug: conbercept, Fixed · Drug: conbercept, PRN · Other: sham injection

Interventions

  • Drugconbercept, Fixed

    intravitreal injection of 0.5 mg conbercept per month, fixed injection

  • Drugconbercept, PRN

    intravitreal injection of 0.5 mg conbercept as need, PRN

  • Othersham injection

    sham intravitreal injection per month, fixed injection

06

What researchers measure

Primary outcomes

  1. mean change from baseline of visual acuity

    to compare the mean change from baseline of best-corrected visual acuity (BCVA) between conbercept treatment group and sham injection group at month 3

    Time frame: 3-month

Secondary outcomes

  1. mean change from baseline of anatomical features

    to compare the difference of mean change from baseline of CRT, CNV size and lesion size between conbercept treatment group and sham injection group at month 3

    Time frame: 3-month

  2. mean change from baseline of visual acuity

    to evaluate the mean change from baseline of BCVA of two groups from month 1 to month 9

    Time frame: 9 months

  3. safety and tolerability of conbercept

    to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9

    Time frame: 3-month and 9-month

07

Study locations

13 sites
  • Peking Union Medical College Hospital
    Beijing, Beijing 100032, China
  • Peking University Third Hospital
    Beijing, Beijing 100083, China
  • Beijing Tongren hospital affiliated to Capital Medical University
    Beijing, Beijing 100730, China
  • Southwest Hospital
    Chongqing, Chongqing 400038, China
  • Daping Hospital, Research Institute of Surgery Third Military Medical University
    Chongqing, Chongqing 400042, China
  • Zhongshan Ophthalmic Center
    Guangzhou, Guangdong 510060, China
  • Wuhan General Hospital of Guangzhou Military
    Wuhan, Hubei 430070, China
  • Wuxi No.2 People's Hospital
    Wuxi, Jiangsu 214002, China
  • Ophthalmologic Hospital of Qingdao
    Qingdao, Shandong 266071, China
  • Shanghai First People's Hospital
    Shanghai, Shanghai 200080, China
  • Xijing Hospital
    Xian, Shanxi 710032, China
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
  • The Affiliated Eye Hospital of WMC
    Wenzhou, Zhejiang 325027, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01809223
Lead sponsor
Chengdu Kanghong Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Mar 12, 2013
Start date
Aug 2012
Primary completion
Feb 2014
Completion
Mar 2015 (estimated)
Last update
Jun 4, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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