Neovascular Age-related Macular DegenerationPhase 1/2HOPENCT01242254
A Study Assessing the Safety and Efficacy of Multiple Intravitreal KH902 in Patients With CNV Due to AMD
A Phase 1/2 study testing Intravitreal injection of KH902 in people with Neovascular Age-related Macular Degeneration, run by Chengdu Kanghong Biotech Co., Ltd. at 3 sites in China.
Trial summary
This study is designed to assess the efficacy and safety of multiple intravitreal injection of KH902 in patients with CNV due to AMD. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Intravitreal injection of KH902
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesChina
- Study dates
- Aug 2009to Feb 2011
- Phase
- Phase 1/2
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the Informed Consent Form by patients or legal representative;
- Men and women ≥ 45 years of age;
- Active primary or recurrent lesions with CNV secondary to neovascular AMD;
- Total lesion size ≤ 12 disc areas in either eye;
- BCVA of the study eyes < 69 letters and the BCVA of fellow eyes ≥ 19 letters;
- Clear ocular media and adequate pupil dilation.
Who cannot join
- CNV lesion secondary to ocular conditions other than neovascular AMD
- History of vitreous hemorrhage, retinal tear, rhegmatogenous retinal detachment or macular hole in the study eye;
- Presence of retinal detachment, retinal pigment epithelial tear, or retinal macular traction in the study eye;
- Anaphylactic disease;
- Uncontrolled glaucoma in either eye;
- Current active ocular inflammation or infection in either eye;
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- Previous anti-VEGF drug treatment in the study eye within three months preceding screening, and/or, for the fellow eye, within one month preceding screening;
- Previous ophthalmologic operation or laser therapy in the study eye within three months preceding screening;
- Current non-healing wound, ulcer, fractures, etc;
- Uncontrolled systemic conditions;
- Patients of child-bearing potential do not adopted adequate contraception methods;
- Pregnant or nursing women.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100000
West China Hospital ,Sichuan University
Chengdu, Sichuan, 610000
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200000
About this study
Official title: An Open Label, Multicenter, Randomized, Uncontrolled Study Assessing the Safety and Efficacy of KH902 in Patients With Choroidal Neovascularization Due to Neovascular Age-related Macular Degeneration(HOPE Study)
This study is designed to assess the efficacy and safety of multiple intravitreal injection of KH902 in patients with CNV due to AMD.
Read the detailed description
Due to conclusions of KH902 Ia study:
Doses of single intravitreal injection of a recombinant human VEGF receptor-Fc fusion protein (KH902) in patients with CNV secondary to neovascular AMD are from 0.05 mg to 3.0 mg. The trial shows that KH902 is safe and tolerable, and no DLT, ophthalmia reaction, endophthalmitis, or systemic AE relevant to the drug is reported, and the main AEs are transient ocular tension increase and micro-hemorrhage in injection site. KH902 appears to produce rapid clinical effects on VA, supported by improvements in anatomical features, in patients with neovascular AMD.
HOPE Study is an open label, multi-center, randomized, uncontrolled dose-and interval-ranging phase Ib study designed to assess the efficacy and safety of multiple intravitreal injection of KH902 at variable dosing regimen in patients with CNV due to AMD. Two groups of patients will initially receive intravitreal administration of KH902 following the randomization:
- Patients in group A will receive monthly intravitreal injections of KH902 for 3 times successively at a dose of 0.5 mg/50 μl/eye;
- Patients in group B will receive monthly intravitreal injections of KH902 for 3 times successively at a dose of 2.0 mg/50 μl/eye.
Following the initial 12-week fixed-dosing phase of the trial:
Patients in group A and group B will continue to receive monthly intravitreal injections of KH902 with 0.5 mg/50 μl/eye or 2.0 mg/50 μl/eye as same as the doses he/she received during the fixed dosing phase, on an as needed (PRN) dosing schedule, based upon the need for re-treatment in accordance with pre-specified criteria up till week 52.
- Being tested
- Intravitreal injection of KH902
- Keywords
- KH902, age-related macular degeneration, choroidal neovascularization, intravitreal injection, multiple injections
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of KH902Biological
0.5 mg 2.0 mg once per 4 weeks during fixed dosing phase once as needed during extended treatment phase
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will receive an intravitreal injection of KH902 0.5mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52 Receives: Biological: Intravitreal injection of KH902 |
| Group B | Experimental | Patients will receive an intravitreal injection of KH902 2.0mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52 Receives: Biological: Intravitreal injection of KH902 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of adverse event
To evaluate the safety of multiple intravitreal injection of KH902 of each group.
Measured: at 52 week
Secondary outcomes (1)
Change from Baseline in BCVA
To evaluate the efficacy of multiple intravitreal injection of KH902 of each group in the mean change from baseline
Measured: Specified timepoints during the screening phase and 52-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison, Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Junjun Zhang, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242254
- Sponsor's protocol ID
- KHSWKH902004
- Acronym
- HOPE
- Status last verified
- Jul 2011
- First submitted
- 10 Nov 2010
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multicenter, Randomized, Uncontrolled Study Assessing the Safety and Efficacy of KH902 in Patients With Choroidal Neovascularization Due to Neovascular Age-related Macular Degeneration(HOPE Study)
- ClinicalTrials.gov ID
- NCT01242254
- Acronym / sponsor ID
- HOPE / KHSWKH902004
- Keywords
- KH902, age-related macular degeneration, choroidal neovascularization, intravitreal injection, multiple injections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison, Air Force Military Medical University, China
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 16 Nov 2010 (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 assess the efficacy and safety of multiple intravitreal injection of KH902 in patients with CNV due to AMD.
Detailed description
Due to conclusions of KH902 Ia study:
Doses of single intravitreal injection of a recombinant human VEGF receptor-Fc fusion protein (KH902) in patients with CNV secondary to neovascular AMD are from 0.05 mg to 3.0 mg. The trial shows that KH902 is safe and tolerable, and no DLT, ophthalmia reaction, endophthalmitis, or systemic AE relevant to the drug is reported, and the main AEs are transient ocular tension increase and micro-hemorrhage in injection site. KH902 appears to produce rapid clinical effects on VA, supported by improvements in anatomical features, in patients with neovascular AMD.
HOPE Study is an open label, multi-center, randomized, uncontrolled dose-and interval-ranging phase Ib study designed to assess the efficacy and safety of multiple intravitreal injection of KH902 at variable dosing regimen in patients with CNV due to AMD. Two groups of patients will initially receive intravitreal administration of KH902 following the randomization:
- Patients in group A will receive monthly intravitreal injections of KH902 for 3 times successively at a dose of 0.5 mg/50 μl/eye;
- Patients in group B will receive monthly intravitreal injections of KH902 for 3 times successively at a dose of 2.0 mg/50 μl/eye.
Following the initial 12-week fixed-dosing phase of the trial:
Patients in group A and group B will continue to receive monthly intravitreal injections of KH902 with 0.5 mg/50 μl/eye or 2.0 mg/50 μl/eye as same as the doses he/she received during the fixed dosing phase, on an as needed (PRN) dosing schedule, based upon the need for re-treatment in accordance with pre-specified criteria up till week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Intravitreal injection of KH902Patients will receive an intravitreal injection of KH902 0.5mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52 |
| Group B | Experimental | Biological: Intravitreal injection of KH902Patients will receive an intravitreal injection of KH902 2.0mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed the Informed Consent Form by patients or legal representative;
- Men and women ≥ 45 years of age;
- Active primary or recurrent lesions with CNV secondary to neovascular AMD;
- Total lesion size ≤ 12 disc areas in either eye;
- BCVA of the study eyes < 69 letters and the BCVA of fellow eyes ≥ 19 letters;
Key exclusion criteria (12 listed)
- CNV lesion secondary to ocular conditions other than neovascular AMD
- History of vitreous hemorrhage, retinal tear, rhegmatogenous retinal detachment or macular hole in the study eye;
- Presence of retinal detachment, retinal pigment epithelial tear, or retinal macular traction in the study eye;
- Anaphylactic disease;
- Uncontrolled glaucoma in either eye;
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 |
|---|---|---|
| Intravitreal injection of KH9020.5 mg 2.0 mg once per 4 weeks during fixed dosing phase once as needed during extended treatment phase | Biological | Group A, Group B |
Primary outcome
The incidence rate of adverse event
Time frame: at 52 week
To evaluate the safety of multiple intravitreal injection of KH902 of each group.
1 secondary outcome
Change from Baseline in BCVA
Time frame: Specified timepoints during the screening phase and 52-week treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
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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.
Junjun Zhang principal investigator
West China Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravitreal injection of KH902 in people with Neovascular Age-related Macular Degeneration, run by Chengdu Kanghong Biotech Co., Ltd. at 3 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 12 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: finished, 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 3 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence rate of adverse event (time frame: at 52 week). 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 27 Mar 2014.