Neovascular Age-related Macular DegenerationPhase 1/2NCT05961007
Evaluation of IBI302 Injection in nAMD or DME
A Phase 1/2 study testing Intravitreal injection of IBI302(dose 1), Intravitreal injection of IBI302(dose 2) and Intravitreal injection of IBI302(dose 3) in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
- What is being tested?
- Intravitreal injection of IBI302(dose 1), Intravitreal injection of IBI302(dose 2) and Intravitreal injection of IBI302(dose 3)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2021to 30 Apr 2024
- 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 18 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 patiensubjects ≥ 18 yrs. of age;
- For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD;
- For DME subjects, Type 1 or type 2 diabetes mellitus, decrease in vision determined to be primarily the result of DME in the study eye; the CST measurement of ≥ 280 μm in the study eye;
- BCVA ETDRS letter score of 24-73 in the study eye;
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 ;
- 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;
- Laser photocoagulation;
Show all 15Show fewer
- History of vitreoretinal surgery;
- Glucocorticoid treatment(intravitreal or peribulbar) ;
- BCVA score <19 letters in the fellow eye;
- Anti-VEGF therapy in the fellow eye within 30 days of day 0;
- Presence of any systemic disease: including but not limited to active infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening); myocardial infarction (within 6 months prior to screening; serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; uncontrolled clinical disease(such as diabetes mellitus, hypertension) 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 90 days of day 0, or attempted to participate in other drug trials during the study;
- Other conditions unsuitable for enrollment judged by investigatiors.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Dose Escalation Study to Evaluate the Safety and Tolerability of IBI302 Intravitreal Injection in Subjects With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema AND A Multi-center, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Diabetic Macular Edema
The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.
- Being tested
- Intravitreal injection of IBI302(dose 1), Intravitreal injection of IBI302(dose 2), Intravitreal injection of IBI302(dose 3), Intravitreal injection of Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of IBI302(dose 1)Biological
IBI302(dose 1) intravitreal injection given as protocol
Intravitreal injection of IBI302(dose 2)Biological
IBI302(dose 2) intravitreal injection given as protocol
Intravitreal injection of IBI302(dose 3)Biological
IBI302(dose 3) intravitreal injection given as protocol
Intravitreal injection of AfliberceptDrug
Aflibercept intravitreal injection given as protocol
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Active comparator | only phase II Receives: Drug: Intravitreal injection of Aflibercept |
| IBI302 | Experimental | Not described Receives: Biological: Intravitreal injection of IBI302(dose 1); Biological: Intravitreal injection of IBI302(dose 2); Biological: Intravitreal injection of IBI302(dose 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of ocular and non-ocular adverse events.
To evaluate the number of subjects with ocular and non-ocular adverse events, treatment emergent adverse event, adverse event of special interest, serious adverse events; number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations.
Measured: Up to week 20
DLT in each group
Measured: 7 days
Secondary outcomes (4)
Change of BCVA from baseline by visit
Best corrected visual acuity (BCVA) was measured on early treatment diabetic retinopathy study(ETDRS) chart at a starting distance of 4 meters. The BCVAletter score ranges from 0 to 100(best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Measured: through study completion，an average of 20 weeks
Change of CST from baseline by visit
Central subfield thickness（CST） was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading.
Measured: through study completion，an average of 20 weeks
Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax)
Measured: through study completion，an average of 20 weeks
The ADA and neutralizing antibody
Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to IBI302 by a validated enzyme-linked immunosorbent assay (ELISA).
Measured: through study completion，an average of 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start18 Nov 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Why it stopped: Company strategy adjustment
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 234 participants (estimated)
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
- NCT05961007
- Sponsor's protocol ID
- CIBI302B201
- Status last verified
- Jul 2023
- First submitted
- 15 Nov 2021
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Study to Evaluate the Safety and Tolerability of IBI302 Intravitreal Injection in Subjects With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema AND A Multi-center, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05961007
- Acronym / sponsor ID
- CIBI302B201
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Company strategy adjustment
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 27 Jul 2023 (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.
The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Active comparator | Drug: Intravitreal injection of Afliberceptonly phase II |
| IBI302 | Experimental | Biological: Intravitreal injection of IBI302(dose 1), Biological: Intravitreal injection of IBI302(dose 2), Biological: Intravitreal injection of IBI302(dose 3) |
Who may qualify
- Ages
- 18 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 patiensubjects ≥ 18 yrs. of age;
- For AMD subjects, active subfoveal or parafoveal CNV secondary to neovascular AMD; the vision decreased by nAMD;
- For DME subjects, Type 1 or type 2 diabetes mellitus, decrease in vision determined to be primarily the result of DME in the study eye; the CST measurement of ≥ 280 μm in the study eye;
- BCVA ETDRS letter score of 24-73 in the study eye;
Key exclusion criteria (15 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 ;
- Presence of active intraocular or periocular inflammation or infection;
- Prior any treatment of following in the study eye:
- BCVA score <19 letters in the fellow 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 IBI302(dose 1)IBI302(dose 1) intravitreal injection given as protocol | Biological | IBI302 |
| Intravitreal injection of IBI302(dose 2)IBI302(dose 2) intravitreal injection given as protocol | Biological | IBI302 |
| Intravitreal injection of IBI302(dose 3)IBI302(dose 3) intravitreal injection given as protocol | Biological | IBI302 |
| Intravitreal injection of AfliberceptAflibercept intravitreal injection given as protocol | Drug | Aflibercept |
Primary outcome
Incidence and severity of ocular and non-ocular adverse events.
Time frame: Up to week 20
To evaluate the number of subjects with ocular and non-ocular adverse events, treatment emergent adverse event, adverse event of special interest, serious adverse events; number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations.
DLT in each group
Time frame: 7 days
4 secondary outcomes
Change of BCVA from baseline by visit
Time frame: through study completion，an average of 20 weeks
Change of CST from baseline by visit
Time frame: through study completion，an average of 20 weeks
Area under the concentration time curve (AUC) and Maximum plasma concentration (Cmax)
Time frame: through study completion，an average of 20 weeks
The ADA and neutralizing antibody
Time frame: through study completion，an average of 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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 1/2 study testing Intravitreal injection of IBI302(dose 1), Intravitreal injection of IBI302(dose 2) and Intravitreal injection of IBI302(dose 3) in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, 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 15 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: paused, as of the sponsor's last update on 27 Jul 2023. 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 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?
Results are not available in the source record.
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?
Incidence and severity of ocular and non-ocular adverse events. (time frame: Up to week 20). 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?
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 Jul 2023.