Neovascular Age-related Macular DegenerationPhase 3PHOENIXNCT01436864
A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD
A Phase 3 study testing Recombinant Human VEGF Receptor-Fc Fusion Protein in people with Neovascular Age-related Macular Degeneration, run by Chengdu Kanghong Biotech Co., Ltd. at 11 sites in China.
Trial summary
This study is designed to prove and confirm the efficacy and safety of multiple injections of human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Recombinant Human VEGF Receptor-Fc Fusion Protein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 11 sitesChina
- Study dates
- Aug 2011to Nov 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the Informed Consent Form;
- Age ≥ 50 years of either gender;
- Total lesion size ≤ 30 mm2 of the study eye;
- BCVA score of the study eye between 73 and 19 letters;
- Clear ocular media and adequate pupil dilation to permit good quality fundus photographic imaging.
- BCVA score of the fellow eye ≥ 19 letters.
Who cannot join
- Current or previous non-exudative AMD diseases which affect the inspection and measurement of macular or the central visual acuity;
- Subretinal hemorrhage area≥ 50% of total lesion size;
- Scar or fibrosis area in study eyes ≥ 50% of total lesion size; or central foveal scar、fibrosis or atrophy of macular in the study eye;
- Presence of retinal pigment epithelial tear, retinal macular tractional, macular epiretinal membrane, and diagnosed with polypoidal choroidal vasculopathy in the study eye;
- Previous anti-VEGF drug treatment in the study eye within six months preceding screening; or anti-VEGF treatment in the fellow eye within three months before screening;
- Previous intraocular or periocular operations, excluding operations on eyelid without hampering the intravitreal injection in the study eye;
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- Previous ophthalmologic operations in the study eye;
- Current active inflammation or infection in either eye;
- Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
- Current systemic administrations which may lead to toxicity in the crystalline lens;
- History of allergy or current allergic response;
- History of surgery within one month preceding enrollment;
- Infectious diseases need systemic administration;
- Systemic autoimmune diseases;
- Any uncontrolled clinical disorders;
- Patients of child-bearing potential do not adopted adequate contraception methods;
- Pregnant or nursing women;
- Patients should be excluded in the opinion of investigators;
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Daping Hospital of the Third Military Medical University
Chongqing, 400042
First Affiliated Hospital of Fujian Medical College
Fuzhou, Fujian, 350005
Ophthalmologic Hospital of Qingdao
Qingdao, Shandong, 266071
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Shanghai First People's Hospital
Shanghai, 200080
Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong, 515041
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027
People's Hospital of Wuhan University
Wuhan, Hubei, 430060
Wuhan General Hospital of Guangzhou Military Command
Wuhan, Hubei, 430070
Wuxi Second People's Hospital
Wuxi, Jiangsu, 214002
About this study
Official title: A Phase 3 Clinical Trial of Intravitreal Injections of Human Recombinant Vascular Endothelial Growth Factor Receptor-Fc Fusion Protein in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
This study is designed to prove and confirm the efficacy and safety of multiple injections of human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.
Read the detailed description
AMD is the leading cause of severe vision loss in people over the age of 65 in the United States and other western countries. A quantity of documents indicate that neovascularization promoted by VEGF is the main cause of visual acuity decline. Patients are starving for a new drug which can notably improve VA with less administration frequency and lower treatment cost.
The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The pre-clinical researches and phase II study showed that KH902 is well-tolerated,and safe, it is effective in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF.
This study is designed to prove and confirm the efficacy and safety of multiple injections of KH902 in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.
- Being tested
- Recombinant Human VEGF Receptor-Fc Fusion Protein
- Keywords
- Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902), age-related macular degeneration (AMD), choroidal neovascularization (CNV), intravitreal injection, best corrected visual acuity (BCVA), central retinal thickness
- 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.
Recombinant Human VEGF Receptor-Fc Fusion ProteinBiological
Intravitreal injection of KH902 once per month
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg KH902 | Experimental | Patients will receive intravitreal injection of KH902 0.5mg/eye once per month for three times in the study eye, and then patients will receive 2 sham injections monthly, respectively, at the end of month 3 (visit 5), and following these injections you will receive intravitreal injection of KH902 once every three months, till month 12 (respectively at month 5, month 8 and month 11) Receives: Biological: Recombinant Human VEGF Receptor-Fc Fusion Protein |
| Sham-injection | Sham comparator | Patients will receive sham injection once per month for three times, and then you will receive intravitreal injection of KH902 0.5mg/eye once per month for three times in the study eye, after three months' treatment they will receive intravitreal injection of KH902 once every three months, till month 12 (respectively at month 8 and month 11. Receives: Biological: Recombinant Human VEGF Receptor-Fc Fusion Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in BCVA
To evaluate the mean change from baseline in best-corrected visual acuity (BCVA) in KH902 treatment group and sham treatment group at month 3 and compare the difference between the values
Measured: at month 3
Secondary outcomes (2)
The incidence rate of adverse event
To evaluate the difference in safety assessment between Conbercept (KH902) group and Sham group at month 3.
Measured: at month 3
Mean change of retinal thickness from baseline
To evaluate the mean change of retinal thickness from baseline in KH902 treatment group or sham treatment group at month 3.
Measured: at month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionNov 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Xun Xu, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436864
- Sponsor's protocol ID
- KHSWKH902005
- Acronym
- PHOENIX
- Status last verified
- Apr 2023
- First submitted
- 19 Sep 2011
- Last updated
- 18 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Trial of Intravitreal Injections of Human Recombinant Vascular Endothelial Growth Factor Receptor-Fc Fusion Protein in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01436864
- Acronym / sponsor ID
- PHOENIX / KHSWKH902005
- Keywords
- Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902), age-related macular degeneration (AMD), choroidal neovascularization (CNV), intravitreal injection, best corrected visual acuity (BCVA), central retinal thickness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Wisconsin, Madison
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Sep 2011 (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 prove and confirm the efficacy and safety of multiple injections of human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.
Detailed description
AMD is the leading cause of severe vision loss in people over the age of 65 in the United States and other western countries. A quantity of documents indicate that neovascularization promoted by VEGF is the main cause of visual acuity decline. Patients are starving for a new drug which can notably improve VA with less administration frequency and lower treatment cost.
The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The pre-clinical researches and phase II study showed that KH902 is well-tolerated,and safe, it is effective in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF.
This study is designed to prove and confirm the efficacy and safety of multiple injections of KH902 in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg KH902 | Experimental | Biological: Recombinant Human VEGF Receptor-Fc Fusion ProteinPatients will receive intravitreal injection of KH902 0.5mg/eye once per month for three times in the study eye, and then patients will receive 2 sham injections monthly, respectively, at the end of month 3 (visit 5), and following these injections you will receive intravitreal injection of KH902 once every three months, till month 12 (respectively at month 5, month 8 and month 11) |
| Sham-injection | Sham comparator | Biological: Recombinant Human VEGF Receptor-Fc Fusion ProteinPatients will receive sham injection once per month for three times, and then you will receive intravitreal injection of KH902 0.5mg/eye once per month for three times in the study eye, after three months' treatment they will receive intravitreal injection of KH902 once every three months, till month 12 (respectively at month 8 and month 11. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed the Informed Consent Form;
- Age ≥ 50 years of either gender;
- Total lesion size ≤ 30 mm2 of the study eye;
- BCVA score of the study eye between 73 and 19 letters;
- Clear ocular media and adequate pupil dilation to permit good quality fundus photographic imaging.
Key exclusion criteria (18 listed)
- Current or previous non-exudative AMD diseases which affect the inspection and measurement of macular or the central visual acuity;
- Subretinal hemorrhage area≥ 50% of total lesion size;
- Scar or fibrosis area in study eyes ≥ 50% of total lesion size; or central foveal scar、fibrosis or atrophy of macular in the study eye;
- Presence of retinal pigment epithelial tear, retinal macular tractional, macular epiretinal membrane, and diagnosed with polypoidal choroidal vasculopathy in the study eye;
- Previous anti-VEGF drug treatment in the study eye within six months preceding screening; or anti-VEGF treatment in the fellow eye within three months before screening;
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 |
|---|---|---|
| Recombinant Human VEGF Receptor-Fc Fusion ProteinIntravitreal injection of KH902 once per month | Biological | 0.5 mg KH902, Sham-injection |
Primary outcome
Mean change from baseline in BCVA
Time frame: at month 3
To evaluate the mean change from baseline in best-corrected visual acuity (BCVA) in KH902 treatment group and sham treatment group at month 3 and compare the difference between the values
2 secondary outcomes
The incidence rate of adverse event
Time frame: at month 3
Mean change of retinal thickness from baseline
Time frame: at month 3
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 18 Apr 2023.
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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.
Xun Xu principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
11 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 Recombinant Human VEGF Receptor-Fc Fusion Protein in people with Neovascular Age-related Macular Degeneration, run by Chengdu Kanghong Biotech Co., Ltd. at 11 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 18 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
Mean change from baseline in BCVA (time frame: at month 3). 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 18 Apr 2023.