Neovascular Age-related Macular DegenerationPhase 1NCT04370379
Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients
A Phase 1 study testing IBI302 (the first dose level), IBI302 (the second dose level) 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 study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients. 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?
- IBI302 (the first dose level), IBI302 (the second dose level) and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2020to 8 May 2021
- 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
- Male or female patient ≥ 50 yrs. of age.
- Active subfoveal or parafoveal CNV secondary to neovascular AMD.
- Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
Who cannot join
- Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);
- Presence of active intraocular or periocular inflammation or infection;
- History of severe hypersensitivity/allergy 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 three months prior to enrollment, or attempted to participate in other drug trials during the study;
- Diabetic patients have any of the following conditions:HbA1c>7.5% when screening;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.
- Being tested
- IBI302 (the first dose level), IBI302 (the second dose level), Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI302 (the first dose level)Drug
q4week (3 injections) followed by PRN dosing
IBI302 (the second dose level)Drug
q4week (3 injections) followed by PRN dosing
AfliberceptDrug
2mg, q4week (3 injections) followed by q8week
| Study group | Role | What they receive |
|---|---|---|
| low dose of IBI302 | Experimental | Not described Receives: Drug: IBI302 (the first dose level) |
| high dose of IBI302 | Experimental | Not described Receives: Drug: IBI302 (the second dose level) |
| 2mg aflibercept | Active comparator | Not described Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography
Measured: Baseline to Day140
Incidence of adverse events
Measured: Baseline to Day140
Secondary outcomes (12)
Changes in central subfield thickness by OCT compared with baseline
Measured: Baseline to Day140
Changes in CNV characteristics and CNV area by FA compared with baseline
Measured: Baseline to Day140
Changes in BCVA compared with baseline
Measured: Baseline to Day140
Positive rate of anti-drug antibody and neutralizing antibody of IBI302
Measured: Baseline to Day140
the area under the drug-time curve from 0 to time t of IBI302
Measured: Baseline to Day140
the area under the curve at the time of 0-infinity of IBI302
Measured: Baseline to Day140
The peak concentration of IBI302
Measured: Baseline to Day140
The peak time of IBI302
Measured: Baseline to Day140
Clearance rate of IBI302
Measured: Baseline to Day140
Half-life of IBI302
Measured: Baseline to Day140
VEGF concentration
Measured: Baseline to Day140
Concentration of complement fragments
Measured: Baseline to Day140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start28 May 2020
- Primary completion30 Apr 2021
- Study completion8 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT04370379
- Sponsor's protocol ID
- CIBI302A102
- Status last verified
- Nov 2021
- First submitted
- 24 Apr 2020
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jia H, Li T, Sun J, Gong Y, Liu H, Wang H, Chen J, Liu W, Lu S, Feng L, Wan Q, Qian L, Wang F, Liu X, Sun X. A Novel Bispecific Fusion Protein Targeting C3b/C4b and VEGF in Patients With nAMD: A Randomized, Open-Label, Phase 1b Study. Am J Ophthalmol. 2023 Apr;248:8-15. doi: 10.1016/j.ajo.2022.11.016. Epub 2022 Nov 21.
PubMed 36410472
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. 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 IBI302 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT04370379
- Acronym / sponsor ID
- CIBI302A102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 May 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 8 May 2021 (actual)
- First posted
- 30 Apr 2020 (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, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose of IBI302 | Experimental | Drug: IBI302 (the first dose level) |
| high dose of IBI302 | Experimental | Drug: IBI302 (the second dose level) |
| 2mg aflibercept | Active comparator | Drug: Aflibercept |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patient ≥ 50 yrs. of age.
- Active subfoveal or parafoveal CNV secondary to neovascular AMD.
- Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
Key exclusion criteria (5 listed)
- Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);
- Presence of active intraocular or periocular inflammation or infection;
- History of severe hypersensitivity/allergy 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 three months prior to enrollment, or attempted to participate in other drug trials during the study;
- Diabetic patients have any of the following conditions:HbA1c>7.5% when 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 |
|---|---|---|
| IBI302 (the first dose level)q4week (3 injections) followed by PRN dosing | Drug | low dose of IBI302 |
| IBI302 (the second dose level)q4week (3 injections) followed by PRN dosing | Drug | high dose of IBI302 |
| Aflibercept2mg, q4week (3 injections) followed by q8week | Drug | 2mg aflibercept |
Primary outcome
Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography
Time frame: Baseline to Day140
Incidence of adverse events
Time frame: Baseline to Day140
12 secondary outcomes
Changes in central subfield thickness by OCT compared with baseline
Time frame: Baseline to Day140
Changes in CNV characteristics and CNV area by FA compared with baseline
Time frame: Baseline to Day140
Changes in BCVA compared with baseline
Time frame: Baseline to Day140
Positive rate of anti-drug antibody and neutralizing antibody of IBI302
Time frame: Baseline to Day140
the area under the drug-time curve from 0 to time t of IBI302
Time frame: Baseline to Day140
the area under the curve at the time of 0-infinity of IBI302
Time frame: Baseline to Day140
The peak concentration of IBI302
Time frame: Baseline to Day140
The peak time of IBI302
Time frame: Baseline to Day140
Clearance rate of IBI302
Time frame: Baseline to Day140
Half-life of IBI302
Time frame: Baseline to Day140
VEGF concentration
Time frame: Baseline to Day140
Concentration of complement fragments
Time frame: Baseline to Day140
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 11 Nov 2021.
- Derived from this study: PubMed 36410472Jia H, Li T, Sun J, Gong Y, Liu H, Wang H, Chen J, Liu W, Lu S, Feng L, Wan Q, Qian L, Wang F, Liu X, Sun X. A Novel Bispecific Fusion Protein Targeting C3b/C4b and VEGF in Patients With nAMD: A Randomized, Open-Label, Phase 1b Study. Am J Ophthalmol. 2023 Apr;248:8-15. doi: 10.1016/j.ajo.2022.11.016. Epub 2022 Nov 21.
Related trials for Neovascular Age-related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Wet Age-related Macular Degeneration
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
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 IBI302 (the first dose level), IBI302 (the second dose level) 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 3 inclusion and 5 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 11 Nov 2021. 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?
Ocular safety, assessed by BCVA, slitlamp examination, ophthalmoscopy, IOP, fundus photography (time frame: Baseline to Day140). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04370379, which also lists 1 linked publication.
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 11 Nov 2021.