Neovascular Age-related Macular DegenerationPhase 1NCT05639530
A Dose Escalation Study of IBI333 in Subjects With Neovascular Age-related Macular Degeneration
A Phase 1 study testing IBI333 in people with Neovascular Age-related Macular Degeneration, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD). 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?
- IBI333
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2023to 23 Apr 2024
- Phase
- Phase 1
- 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
- Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
- Male or female patients ≥ 50 yrs. of age.
- Active CNV lesions secondary to neovascular AMD.
- BCVA score of 19-78 letters using ETDRS charts in the study eye.
- Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment.
Who cannot join
- Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
- Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye;
- Active ocular or periocular inflammation/infection in either eye;
- Prior any treatment of following in the study eye:
- Anti-VEGF therapy within 90 days prior to screening;
- Intraocular glucocorticoid injection within 180 days prior to screening;
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- Laser photocoagulation or photodynamic therapy within 90 days prior to screening;
- Intraocular surgery within 90 days prior to screening;
- Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening;
- Glycated hemoglobin (HbA1c) > 8% within 28 days prior to screening;
- Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg);
- Systemic administration of steroids within 30 days prior to screening;
- Systemic administration of anti-VEGF drugs within 90 days prior to screening;
- History of severe hypersensitivity/allergic to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
- Participated in any clinical study of any other drug within 90 days 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.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 101199
About this study
Official title: A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI333 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
This study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).
- Being tested
- IBI333
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI333Biological
Intravitreal injection of IBI333
| Study group | Role | What they receive |
|---|---|---|
| :treated with different doses of single intravitreal injections of IBI333 | Experimental | Biological: IBI333 Dose 1 IBI333 of single IVT injections，
Biological: IBI333 Dose 2 IBI333 of single IVT injections Receives: Biological: IBI333 |
| treated with different doses of multiple intravitreal injections of IBI333 | Experimental | Biological: IBI333 Dose 3 IBI333 of multiple IVT injections，
Biological: IBI333 Dose 4 IBI333 of multiple IVT injections Receives: Biological: IBI333 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance indicators
- Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE);
- Incidence of dose limiting toxicity;
Measured: Through study completion, a maximum of 24 weeks
Secondary outcomes (9)
The area under the curve (AUC) of serum concentration of the drug after the administration.
Measured: Through study completion, a maximum of 24 weeks
Maximum concentration (Cmax) of the drug after the administration.
Measured: Through study completion, a maximum of 24 weeks
Time at which maximum concentration (Tmax) occurs for the drug after the administration.
Measured: Through study completion, a maximum of 24 weeks
The half-life (t1/2) of drug after the administration .
Measured: Through study completion, a maximum of 24 weeks
Number of participants with anti-drug antibodies or neutralizing antibodies .
Measured: Through study completion, a maximum of 24 weeks
Changes of BCVA measured by ETDRS chart from baseline.
Measured: Through study completion, a maximum of 24 weeks
Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline.
Measured: Through study completion, a maximum of 24 weeks
Proportion of subjects without intraretinal or subretinal fluid on SD-OCT.
Measured: Through study completion, a maximum of 24 weeks
Change of height of pigment epithelial detachment from baseline on SD-OCT.
Measured: Through study completion, a maximum of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start27 Feb 2023
- Primary completion7 Dec 2023
- Study completion23 Apr 2024
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT05639530
- Sponsor's protocol ID
- CIBI333A101
- Status last verified
- Aug 2024
- First submitted
- 14 Nov 2022
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI333 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT05639530
- Acronym / sponsor ID
- CIBI333A101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 6 Dec 2022 (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 study is designed for multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injection of IBI333 in subjects with neovascular age-related macular degeneration (nAMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| :treated with different doses of single intravitreal injections of IBI333 | Experimental | Biological: IBI333Biological: IBI333 Dose 1 IBI333 of single IVT injections， Biological: IBI333 Dose 2 IBI333 of single IVT injections |
| treated with different doses of multiple intravitreal injections of IBI333 | Experimental | Biological: IBI333Biological: IBI333 Dose 3 IBI333 of multiple IVT injections， Biological: IBI333 Dose 4 IBI333 of multiple IVT injections |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
- Male or female patients ≥ 50 yrs. of age.
- Active CNV lesions secondary to neovascular AMD.
- BCVA score of 19-78 letters using ETDRS charts in the study eye.
- Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment.
Key exclusion criteria (16 listed)
- Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
- Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye;
- Active ocular or periocular inflammation/infection in either eye;
- Prior any treatment of following in the study eye:
- Glycated hemoglobin (HbA1c) > 8% within 28 days prior to 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 |
|---|---|---|
| IBI333Intravitreal injection of IBI333 | Biological | :treated with different doses of single intravitreal injections of IBI333, treated with different doses of multiple intravitreal injections of IBI333 |
Primary outcome
Safety and tolerance indicators
Time frame: Through study completion, a maximum of 24 weeks
1. Incidence, relatedness and severity of all adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE); 2. Incidence of dose limiting toxicity;
9 secondary outcomes
The area under the curve (AUC) of serum concentration of the drug after the administration.
Time frame: Through study completion, a maximum of 24 weeks
Maximum concentration (Cmax) of the drug after the administration.
Time frame: Through study completion, a maximum of 24 weeks
Time at which maximum concentration (Tmax) occurs for the drug after the administration.
Time frame: Through study completion, a maximum of 24 weeks
The half-life (t1/2) of drug after the administration .
Time frame: Through study completion, a maximum of 24 weeks
Number of participants with anti-drug antibodies or neutralizing antibodies .
Time frame: Through study completion, a maximum of 24 weeks
Changes of BCVA measured by ETDRS chart from baseline.
Time frame: Through study completion, a maximum of 24 weeks
Changes of CST measured by spectral domain optical coherence tomography (SD-OCT) from baseline.
Time frame: Through study completion, a maximum of 24 weeks
Proportion of subjects without intraretinal or subretinal fluid on SD-OCT.
Time frame: Through study completion, a maximum of 24 weeks
Change of height of pigment epithelial detachment from baseline on SD-OCT.
Time frame: Through study completion, a maximum of 24 weeks
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 4 Sep 2024.
- Individual participant dataSharing planned: No
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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 1 study testing IBI333 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 5 inclusion and 16 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 4 Sep 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 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.
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?
Safety and tolerance indicators (time frame: Through study completion, a maximum of 24 weeks). 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 Sep 2024.