Neovascular Age-related Macular DegenerationPhase 2NCT04820452
A Study of IBI302 in Patients With nAMD
A Phase 2 study testing Low dose IBI302, High dose IBI302 and Aflibercept in people with Neovascular Age-related Macular Degeneration, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration. 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?
- Low dose IBI302, High dose IBI302 and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2021to 13 Jan 2023
- 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
- Male or female patient ≥ 50 yrs. of age.
- Active subfoveal or parafoveal CNV secondary to neovascular AMD.
- BCVA score of 24-73 letters using ETDRS charts in the study eye.
- Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
Who cannot join
- Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
- Presence of uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg despite the standardized treatment);
- Presence of active intraocular or periocular inflammation or infection;
- Prior any treatment of following in the study eye:
- Anti-VEGF therapy or anti-complement therapy within 3 months prior to screening;
- Laser photocoagulation within 3 months prior to screening;
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- Photodynamic therapy or vitreoretinal surgery;
- Intraocular glucocorticoid injection within 6 months prior to enrollment;
- Presence of any systemic disease: including but not limited toactive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
- History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
- Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
- Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
- Other conditions unsuitable for enrollment judged by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Active-controlled Phase II Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Neovascular Age-related Macular Degeneration
This is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.
- Being tested
- Low dose IBI302, High dose IBI302, Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose IBI302Biological
Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection
High dose IBI302Biological
High dose IBI302 intravitreal injection given as every other month after three loading monthly injection
AfliberceptDrug
Intraocular injection
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 IBI302 treated with high dose level of IBI302 | Experimental | Drug: IBI302 4mg/eye;Intraocular injection Receives: Biological: High dose IBI302 |
| Aflibercept | Active comparator | Drug: Aflibercept 2mg/eye;Intraocular injection Receives: Drug: Aflibercept |
| cohort 1 IBI302 treated with low dose level of IBI302 | Experimental | Drug: IBI302 2mg/eye;Intraocular injection Receives: Biological: Low dose IBI302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The visual efficacy of IBI302
Measured: Baseline to week 36
Secondary outcomes (5)
other visual effects of IBI302
the proportion if BCVA improvement ≥0,5,10 or 15 letters at week 12, 28, 36 and 52.
Measured: Baseline to week 52
the anatomical effects of IBI302 on OCT
the mean change of central subfield thickness from BL to week 52 at week 12, 28, 36 and 52
Measured: Baseline to week 52
the anatomical effects of IBI302 on FFA
the change of CNV area, CNV leakage area, total lesion area from BL to week 36 or 52
Measured: Baseline to week 52
the safety of IBI302
the incidence of ocular AE or any systemic AE, TEAE, SAE
Measured: Baseline to week 52
Immunogenicity of IBI302
the positive rate of anti-drug antibody and neutralizing antibody
Measured: Baseline to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start28 Apr 2021
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
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.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820452
- Sponsor's protocol ID
- CIBI302A201
- Status last verified
- Nov 2024
- First submitted
- 25 Mar 2021
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Active-controlled Phase II Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04820452
- Acronym / sponsor ID
- CIBI302A201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 29 Mar 2021 (actual)
- 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 is a multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort 1 IBI302 treated with high dose level of IBI302 | Experimental | Biological: High dose IBI302Drug: IBI302 4mg/eye;Intraocular injection |
| Aflibercept | Active comparator | Drug: AfliberceptDrug: Aflibercept 2mg/eye;Intraocular injection |
| cohort 1 IBI302 treated with low dose level of IBI302 | Experimental | Biological: Low dose IBI302Drug: IBI302 2mg/eye;Intraocular injection |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patient ≥ 50 yrs. of age.
- Active subfoveal or parafoveal CNV secondary to neovascular AMD.
- BCVA score of 24-73 letters using ETDRS charts in the study eye.
- Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
Key exclusion criteria (13 listed)
- Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
- Presence of uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg despite the standardized treatment);
- Presence of active intraocular or periocular inflammation or infection;
- Prior any treatment of following in the study eye:
- Presence of any systemic disease: including but not limited toactive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
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 |
|---|---|---|
| Low dose IBI302Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection | Biological | cohort 1 IBI302 treated with low dose level of IBI302 |
| High dose IBI302High dose IBI302 intravitreal injection given as every other month after three loading monthly injection | Biological | cohort 1 IBI302 treated with high dose level of IBI302 |
| AfliberceptIntraocular injection | Drug | Aflibercept |
Primary outcome
The visual efficacy of IBI302
Time frame: Baseline to week 36
5 secondary outcomes
other visual effects of IBI302
Time frame: Baseline to week 52
the anatomical effects of IBI302 on OCT
Time frame: Baseline to week 52
the anatomical effects of IBI302 on FFA
Time frame: Baseline to week 52
the safety of IBI302
Time frame: Baseline to week 52
Immunogenicity of IBI302
Time frame: Baseline to week 52
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 Nov 2024.
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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.
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 Low dose IBI302, High dose IBI302 and Aflibercept in people with Neovascular Age-related Macular Degeneration, run by Innovent Biologics (Suzhou) 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 4 inclusion and 13 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 Nov 2024. 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?
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 visual efficacy of IBI302 (time frame: Baseline to week 36). 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 Nov 2024.