Very Low Vision Secondary to Wet Age-related Macular DegenerationPhase 2LAMPNCT02098720
An Open, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration (wAMD)
A Phase 2 study testing Conbercept in people with Very Low Vision Secondary to Wet Age-related Macular Degeneration, run by Chengdu Kanghong Biotech Co., Ltd. at 1 site in China.
Trial summary
This study is designed to evaluate the effect of Conbercept therapy on visual acuity and anatomic outcomes and safety observed in subjects with very low vision secondary to wet age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Very Low Vision Secondary to Wet Age-related Macular Degeneration
- 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to 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 50 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:
- There are primary or recurrent subfoveal or parafoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
- The criterion of active CNV should meet at least one of following three conditions :
- fresh bleeding;
- neurosensory detachment showed on optical coherence tomography(OCT);
- leakage showed on fundus fluorescein angiography (FFA).
- BCVA in study eye < 19 letters (approximately 20/400 Snellen equivalent).
Who cannot join
- Past or existing non-exudative AMD in study eye decided by investigator that have affected macular detection or central vision;
- Subretinal hemorrhage in study eye and bleeding area ≥6 disc areas;
- History of vitreous hemorrhage within last month;
- The maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye;
- Photodynamic therapy (PDT) or drug treatment of CNV within last 6 months in study eye, or anti-vascular endothelial growth factor (VEGF) therapy in fellow eye within last month;
- History of glaucoma in study eye;
- Aphakia (excluding artificial lens) in the study eye.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center,Sun yat-sen University
Guangzhou, Guangdong
About this study
Official title: An Open, Non-randomize, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration
This study is designed to evaluate the effect of Conbercept therapy on visual acuity and anatomic outcomes and safety observed in subjects with very low vision secondary to wet age-related macular degeneration.
- Being tested
- Conbercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConberceptDrug
| Study group | Role | What they receive |
|---|---|---|
| Conbercept | Experimental | Subjects will receive Conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 3 months, the investigator will decide whether repeat injections are needed based on the monthly assessment results. Receives: Drug: Conbercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain
Measured: 6-month
Secondary outcomes (3)
mean change in BCVA from baseline
Measured: 6-month
change from baseline of macular area thickness and other anatomy results
Measured: 6-month
safety of Conbercept therapy
To assess incidence of adverse events, incidence of adverse drug reactions etc.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startDec 2011
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Vision Secondary to Wet Age-related Macular DegenerationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT02098720
- Sponsor's protocol ID
- KHSWKH902009
- Acronym
- LAMP
- Status last verified
- Jul 2014
- First submitted
- 25 Mar 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-randomize, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02098720
- Acronym / sponsor ID
- LAMP / KHSWKH902009
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2014 (actual)
- First posted
- 28 Mar 2014 (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 designed to evaluate the effect of Conbercept therapy on visual acuity and anatomic outcomes and safety observed in subjects with very low vision secondary to wet age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conbercept | Experimental | Drug: ConberceptSubjects will receive Conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 3 months, the investigator will decide whether repeat injections are needed based on the monthly assessment results. |
Who may qualify
- Ages
- 50 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:
- There are primary or recurrent subfoveal or parafoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
- BCVA in study eye < 19 letters (approximately 20/400 Snellen equivalent).
Key exclusion criteria (7 listed)
- Past or existing non-exudative AMD in study eye decided by investigator that have affected macular detection or central vision;
- Subretinal hemorrhage in study eye and bleeding area ≥6 disc areas;
- History of vitreous hemorrhage within last month;
- The maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye;
- Photodynamic therapy (PDT) or drug treatment of CNV within last 6 months in study eye, or anti-vascular endothelial growth factor (VEGF) therapy in fellow eye within last month;
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 | Drug | Conbercept |
Primary outcome
percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain
Time frame: 6-month
3 secondary outcomes
mean change in BCVA from baseline
Time frame: 6-month
change from baseline of macular area thickness and other anatomy results
Time frame: 6-month
safety of Conbercept therapy
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conbercept in people with Very Low Vision Secondary to Wet Age-related Macular Degeneration, run by Chengdu Kanghong Biotech Co., Ltd. at 1 site 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 7 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 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain (time frame: 6-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 22 Jul 2014.