Neovascular Age-related Macular DegenerationPhase 3NCT05972473
A Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With nAMD
A Phase 3 study testing Aflibercept Ophthalmic and 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-contralled study to evaluate effective and security 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?
- Aflibercept Ophthalmic and IBI302
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2023to 30 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Signed informed consent must be obtained prior to study participation;
- Male or female ≥ 50 years of age at the time of signing the informed consent;
- Active subfoveal CNV secondary to nAMD, or active CNV with intra/subretinal fluid involving the fovea;
- BCVA of 19 to 78 ETDRS letters (inclusive) in the study eye at baseline.
Who cannot join
- Ocular disease:
- Any concurrent intraocular condition/systemic disease in the study eye at screening or baseline that, in the judgment of the investigator, may cause the participant fail to respond to the treatment or confuse the interpretation of study results;
- Total lesion area(including blood, atrophy, fibrosis, PED and neovascularization)> 12 optic disc area (DA) on FFA;
- Subretinal hemorrhage area > 50% of the total lesion area, or subretinal hemorrhage area involving macular fovea ≥ 1 DA;
- Fibrosis or atrophy area > 50% of the total lesion area, or involving the fovea; Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg after standard treatment);
- Presence of active intraocular or periocular infection or inflammation;
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- Ocular treatment:
- Anti-VEGF or anti-complement therapy in the study eye within 90 days prior to baseline;
- Fundus laser photo-coagulation in the study eye within 90 days prior to baseline;
- Photodynamic Therapy (PDT) in the study eye within 90 days prior to baseline;
- History of vitreoretinal surgery, penetrating keratoplasty in the study eye;
- General condition or treatment:
- Uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg after standard treatment);
- HbA1c > 8% within 28 days prior to baseline; Systemic anti-VEGF drug and anti-complement drug therapy within 90 days prior to baseline;
- History of hypersensitivity to any component of the test article, control article, or clinically relevant sensitivity to fluorescein dye, povidone-iodine;
- Pregnant or lactating women; Inappropriate for the study (e.g., substance abuse, inability or unwillingness to follow the trial protocol), as judged by the investig.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Randomized, Double-masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravitreal IBI302(Efdamrofusp Alfa) in Subjects With Neovascular Age-Related Macular Degeneration
The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.
- Being tested
- Aflibercept Ophthalmic, IBI302
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept OphthalmicDrug
2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W).
IBI302Biological
8 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Active comparator | Drug: Aflibercept 2mg/eye; Intraocular injection Receives: Drug: Aflibercept Ophthalmic |
| IBI302 dose 8mg | Experimental | Drug: IBI302 8mg/eye; Intraocular injection Receives: Biological: IBI302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in Best corrected visual acuity ( BCVA ) in the study eye.
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 44, 48, 52.
Measured: At week 44, 48, 52
Secondary outcomes (6)
The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16
The intraretinal fluid and subretinal fluid is measured by optical coherence tomography (OCT) in the central subfield(center 1 millimeter)
Measured: At week 16
Change from baseline in BCVA at Week 52 and 100
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: Upto Week 100
Change from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100
Central subfield thickness was defined as the distance between the internal limiting member and the Bruch's member using OCT, as assessed by the central reading center.
Measured: Upto Week 100
Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100
the area of the choroidal neovascularization lesion in the study eye was measured by a central reading center using FFA
Measured: Upto Week 100
Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100
Percentages are based on number of participants randomized to the IBI302 group who have not discontinued the study at week 52 and 100. the treatment interval at a givven visit is defined as the treatment interval decision followed at that visit.
Measured: Upto Week 100
Incidence, relatedness to the study drug and severity of ocular and Non-ocular adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE).
All AEs were recorded and the investigator made an assessment of seriousness,severity, and causality of each AE.
Measured: Upto Week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start21 Sep 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 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
- NCT05972473
- Sponsor's protocol ID
- CIBI302A301CN
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2023
- Last updated
- 13 Mar 2025
- 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravitreal IBI302(Efdamrofusp Alfa) in Subjects With Neovascular Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05972473
- Acronym / sponsor ID
- CIBI302A301CN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 2 Aug 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 study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security 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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Active comparator | Drug: Aflibercept OphthalmicDrug: Aflibercept 2mg/eye; Intraocular injection |
| IBI302 dose 8mg | Experimental | Biological: IBI302Drug: IBI302 8mg/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)
- Signed informed consent must be obtained prior to study participation;
- Male or female ≥ 50 years of age at the time of signing the informed consent;
- Active subfoveal CNV secondary to nAMD, or active CNV with intra/subretinal fluid involving the fovea;
- BCVA of 19 to 78 ETDRS letters (inclusive) in the study eye at baseline.
Key exclusion criteria (16 listed)
- Ocular disease:
- Ocular treatment:
- General condition or treatment:
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 |
|---|---|---|
| Aflibercept Ophthalmic2mg Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive monthes, folloesd by once every 8 weeks(Q8W). | Drug | Aflibercept |
| IBI3028 mg IBI302 will be administered by intraitreal injection into the study eye at intervals as specified in the study protocol. | Biological | IBI302 dose 8mg |
Primary outcome
Mean change from baseline in Best corrected visual acuity ( BCVA ) in the study eye.
Time frame: At week 44, 48, 52
Change from Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 44, 48, 52.
6 secondary outcomes
The proportion of participants with absence intraretinal fluid (IRF) and absence subretinal fluid (SRF) in the fovea at Week 16
Time frame: At week 16
Change from baseline in BCVA at Week 52 and 100
Time frame: Upto Week 100
Change from baseline in central subfield thickness (CST) measured by optical coherence tomography (OCT) at Week 52 and 100
Time frame: Upto Week 100
Change from baseline in area of CNV on fundus fluorescence angiography (FFA) at Week 52 and 100
Time frame: Upto Week 100
Proportion of participants on a q8W, q12W, and q16W treatment intervals at Week 52 and 100
Time frame: Upto Week 100
Incidence, relatedness to the study drug and severity of ocular and Non-ocular adverse events (AE), treatment emergent adverse events (TEAE) and serious adverse events (SAE).
Time frame: Upto Week 100
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- 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 3 study testing Aflibercept Ophthalmic and 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 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Mean change from baseline in Best corrected visual acuity ( BCVA ) in the study eye. (time frame: At week 44, 48, 52). 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 13 Mar 2025.