Neovascular Age-related Macular DegenerationPhase 2NCT05403749
A Study of Longer Interval of IVT IBI302 in Subjects With nAMD
A Phase 2 study testing dose 1 IBI302, Aflibercept and dose 2 IBI302 in people with Neovascular Age-related Macular Degeneration, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection 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?
- dose 1 IBI302, Aflibercept and dose 2 IBI302
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2022to 13 May 2024
- 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
- Willing and able to sign informed consent from and comply with visit and study procedures per protocol.
- Male or female patients≥50 yrs. of age.
- Active subfoveal or parafoveal CNV secondary to neovascular AMD on FFA or OCT.
- The CNV area≥50% lesion area on FFA in the study eye at screening visit.
- BCVA score of 24-78 letters using ETDRS charts in the study eye at the baseline.
Who cannot join
- Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
- Subretinal hemorrhage>50% total lesion area and/or involvement in the macular foveal, fibrosis or atrophy area>50% total lesion area and/or involved of macular fovea;
- Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)
- Presence of active intraocular or periocular inflammation or infection;
- Prior any treatment of following in the study eye:
- Anti-VEGF(Vascular Endothelial Growth Factor) therapy or anti-complement therapy within 3 months prior to screening;
Show all 14Show fewer
- Laser photocoagulation within 3 months prior to screening;
- Photodynamic therapy or vitreoretinal surgery;
- Intraocular glucocorticoid injection within 6 months prior to enrollment;
- Presence of any systemic disease: including but not limited tractive 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.
China1 site
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
About this study
Official title: A Multi-center, Randomized, Double-masked, Active-controlled Study to Evaluate the Longer Interval of Intravitreal (IVT) Injection of IBI302 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.
- Being tested
- dose 1 IBI302, Aflibercept, dose 2 IBI302
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dose 1 IBI302Biological
After 4 loading monthly intravitreal injections of dose 1 IBI302，the following IBI302 IVT is given as descript in protocol.
AfliberceptDrug
Three consecutive monthly intravitreal injections of 2.0mg Aflibercept followed by injection every other month
dose 2 IBI302Biological
After 4 loading monthly intravitreal injections of dose 2 IBI302，the following IBI302 IVT is given as descript in protocol
| Study group | Role | What they receive |
|---|---|---|
| IBI302 dose 2 group | Experimental | Drug: Aflibercept 8mg/eye;Intraocular injection Receives: Biological: dose 2 IBI302 |
| Aflibercept | Active comparator | Drug: Aflibercept 2mg/eye;Intraocular injection Receives: Drug: Aflibercept |
| IBI302 dose 1 group | Experimental | Drug: Aflibercept 6.4mg/eye;Intraocular injection Receives: Biological: dose 1 IBI302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of BCVA from baseline
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
Measured: Baseline to week 40
Secondary outcomes (7)
Percentage of Participants Loss >0,≥5,10，15 Letters From the Baseline BCVA in the Study Eye Over Time
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a loss in BCVA letter score from baseline indicates a decline in visual acuity.
Measured: Baseline to week 52
Change of Central Subfield Thickness in the Study Eye from baseline
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane using optical coherence tomography (OCT), as assessed by the central reading center.
Measured: Baseline to week 52
Change of Total Area of Choroidal Neovascularization (CNV) Lesion/Total Area of Choroidal Neovascularization Leakage in the Study Eye from Baseline
The total area of the choroidal neovascularization lesion/Total Area of Choroidal Neovascularization Leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Measured: From Baseline to week 52
Percentage of Participants in different dosage of IBI302 Arm on Once Every 8-Weeks, 12-Weeks,Treatment Intervals
Measured: At Week 20,40,52
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the study. AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs of special interest. The investigator independently assessed the seriousness and severity for each AE. Severity was graded according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity.
Measured: From Baseline to week 52
Percentage of Participants Gaining ≥0,5,10,15 Letters From the Baseline BCVA in the Study Eye Over Time
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
Measured: From Baseline to week 52
Immunogenicity end points
Production of anti-drug antibodies in serum.
Measured: From 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 posted3 Jun 2022
- Study start29 Jun 2022
- Primary completion13 May 2024
- Study completion13 May 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 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
- NCT05403749
- Sponsor's protocol ID
- CIBI302A202
- Status last verified
- Jun 2024
- First submitted
- 20 May 2022
- Last updated
- 28 Jun 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 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-masked, Active-controlled Study to Evaluate the Longer Interval of Intravitreal (IVT) Injection of IBI302 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT05403749
- Acronym / sponsor ID
- CIBI302A202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 3 Jun 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.
The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI302 dose 2 group | Experimental | Biological: dose 2 IBI302Drug: Aflibercept 8mg/eye;Intraocular injection |
| Aflibercept | Active comparator | Drug: AfliberceptDrug: Aflibercept 2mg/eye;Intraocular injection |
| IBI302 dose 1 group | Experimental | Biological: dose 1 IBI302Drug: Aflibercept 6.4mg/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 (5 listed)
- Willing and able to sign informed consent from and comply with visit and study procedures per protocol.
- Male or female patients≥50 yrs. of age.
- Active subfoveal or parafoveal CNV secondary to neovascular AMD on FFA or OCT.
- The CNV area≥50% lesion area on FFA in the study eye at screening visit.
- BCVA score of 24-78 letters using ETDRS charts in the study eye at the baseline.
Key exclusion criteria (14 listed)
- Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
- Subretinal hemorrhage>50% total lesion area and/or involvement in the macular foveal, fibrosis or atrophy area>50% total lesion area and/or involved of macular fovea;
- Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)
- Presence of active intraocular or periocular inflammation or infection;
- Prior any treatment of following in the study 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 |
|---|---|---|
| dose 1 IBI302After 4 loading monthly intravitreal injections of dose 1 IBI302，the following IBI302 IVT is given as descript in protocol. | Biological | IBI302 dose 1 group |
| AfliberceptThree consecutive monthly intravitreal injections of 2.0mg Aflibercept followed by injection every other month | Drug | Aflibercept |
| dose 2 IBI302After 4 loading monthly intravitreal injections of dose 2 IBI302，the following IBI302 IVT is given as descript in protocol | Biological | IBI302 dose 2 group |
Primary outcome
Change of BCVA from baseline
Time frame: Baseline to week 40
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
7 secondary outcomes
Percentage of Participants Loss >0,≥5,10，15 Letters From the Baseline BCVA in the Study Eye Over Time
Time frame: Baseline to week 52
Change of Central Subfield Thickness in the Study Eye from baseline
Time frame: Baseline to week 52
Change of Total Area of Choroidal Neovascularization (CNV) Lesion/Total Area of Choroidal Neovascularization Leakage in the Study Eye from Baseline
Time frame: From Baseline to week 52
Percentage of Participants in different dosage of IBI302 Arm on Once Every 8-Weeks, 12-Weeks,Treatment Intervals
Time frame: At Week 20,40,52
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Time frame: From Baseline to week 52
Percentage of Participants Gaining ≥0,5,10,15 Letters From the Baseline BCVA in the Study Eye Over Time
Time frame: From Baseline to week 52
Immunogenicity end points
Time frame: From 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 28 Jun 2024.
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 2 study testing dose 1 IBI302, Aflibercept and dose 2 IBI302 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 14 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 28 Jun 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?
Change of BCVA from baseline (time frame: Baseline to week 40). 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 28 Jun 2024.