Choroid Neovascularization Secondary to Degenerative MyopiaPhase 3SHINYNCT01809223
A Randomized, Double-blind, Multicenter, Sham-controlled, Safety and Efficacy Study of Conbercept in Patients With mCNV
A Phase 3 study testing conbercept, Fixed and conbercept, PRN in people with Choroid Neovascularization Secondary to Degenerative Myopia, run by Chengdu Kanghong Biotech Co., Ltd. at 13 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroid Neovascularization Secondary to Degenerative Myopia
- What is being tested?
- conbercept, Fixed and conbercept, PRN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 13 sitesChina
- Study dates
- Aug 2012to Mar 2015
- Phase
- Phase 3
- 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
- Patients give fully informed consent and are willing and able to comply with all study procedures.
- 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.
- The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent)
Who cannot join
- Current vitreous hemorrhage in either eye.
- Intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye.
- Active infectious ocular inflammation in either eye.
- Fibrosis or atrophy involving the center of foveal in the study eye.
- 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.
- The lesion size ≥30 mm2 in the study eye.
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- Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results.
- Uncontrolled glaucoma or cup/disk ratio > 0.8 in the study eye.
- Aphakia (excluding artificial lens) in the study eye.
- Serious amblyopia and amaurosis in the fellow eye.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Peking University Third Hospital
Beijing, Beijing Municipality, 100083
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100730
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Daping Hospital, Research Institute of Surgery Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
Ophthalmologic Hospital of Qingdao
Qingdao, Shandong, 266071
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
The Affiliated Eye Hospital of WMC
Wenzhou, Zhejiang, 325027
Wuhan General Hospital of Guangzhou Military
Wuhan, Hubei, 430070
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, 214002
Xijing Hospital
Xian, Shanxi, 710032
About this study
Official title: The Safety and Efficacy of Conbercept in the Treatment of Choroidal Neovascularization (CNV) Secondary to High Myopia
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.
- Being tested
- conbercept, Fixed, conbercept, PRN, sham injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conbercept, FixedDrug
intravitreal injection of 0.5 mg conbercept per month, fixed injection
conbercept, PRNDrug
intravitreal injection of 0.5 mg conbercept as need, PRN
sham injectionOther
sham intravitreal injection per month, fixed injection
| Study group | Role | What they receive |
|---|---|---|
| conbercept treatment group | Experimental | 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. Receives: Drug: conbercept, Fixed; Drug: conbercept, PRN |
| sham injection group | Sham comparator | 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. Receives: Drug: conbercept, Fixed; Drug: conbercept, PRN; Other: sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3-month
Secondary outcomes (3)
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
Measured: 3-month
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
Measured: 9 months
safety and tolerability of conbercept
to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9
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.
- First posted12 Mar 2013 (estimated)
- Study startAug 2012
- Primary completionFeb 2014
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroid Neovascularization Secondary to Degenerative MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809223
- Sponsor's protocol ID
- KHSWKH902007
- Acronym
- SHINY
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2013
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Conbercept in the Treatment of Choroidal Neovascularization (CNV) Secondary to High Myopia
- ClinicalTrials.gov ID
- NCT01809223
- Acronym / sponsor ID
- SHINY / KHSWKH902007
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 12 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conbercept treatment group | Experimental | Drug: conbercept, Fixed, Drug: conbercept, PRNSubjects 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. |
| sham injection group | Sham comparator | Drug: conbercept, Fixed, Drug: conbercept, PRN, Other: sham injectionSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients give fully informed consent and are willing and able to comply with all study procedures.
- In the study eye:
- The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent)
Key exclusion criteria (10 listed)
- Current vitreous hemorrhage in either eye.
- Intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye.
- Active infectious ocular inflammation in either eye.
- Fibrosis or atrophy involving the center of foveal in the study eye.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conbercept, Fixedintravitreal injection of 0.5 mg conbercept per month, fixed injection | Drug | conbercept treatment group, sham injection group |
| conbercept, PRNintravitreal injection of 0.5 mg conbercept as need, PRN | Drug | conbercept treatment group, sham injection group |
| sham injectionsham intravitreal injection per month, fixed injection | Other | sham injection group |
Primary outcome
mean change from baseline of visual acuity
Time frame: 3-month
to compare the mean change from baseline of best-corrected visual acuity (BCVA) between conbercept treatment group and sham injection group at month 3
3 secondary outcomes
mean change from baseline of anatomical features
Time frame: 3-month
mean change from baseline of visual acuity
Time frame: 9 months
safety and tolerability of conbercept
Time frame: 3-month and 9-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing conbercept, Fixed and conbercept, PRN in people with Choroid Neovascularization Secondary to Degenerative Myopia, run by Chengdu Kanghong Biotech Co., Ltd. at 13 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 8 inclusion and 10 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 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 of visual acuity (time frame: 3-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2014.