Neovascular Age-related Macular DegenerationPhase 2NCT07275840
A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD
A Phase 2 study testing IBI302 8mg dose in people with Neovascular Age-related Macular Degeneration, run by Innovent Biologics Technology Limited (Shanghai R&D Center) at 1 site in China.
Trial summary
This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD 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 8mg dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2025to 30 Aug 2026
- Phase
- Phase 2
- 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
- Have signed an informed consent form before participating in the research.
- Male or female individuals aged 50 or above at the time of signing the informed consent form;
- Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea.
- At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).
Who cannot join
- According to the investigator's judgment, concomitant ocular diseases/systemic diseases of the study eyes at screening or baseline may lead to participants' non-response to the study treatment or confuse the interpretation of the study results;
- The study eye has uncontrollable glaucoma;
- There is an active intraocular or periocular infection or inflammation in either eye;
- The non-study eye has severe visual function disorders;
- Within 90 days before baseline, the study eye had received anti-VEGF treatment;
- Within 90 days before baseline, the study eye had received anti-complement treatment;
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- At any time before baseline, the study eye had received IBI302 treatment;
- Uncontrollable hypertension;
- Glycated hemoglobin (HbA1c) > 10.0% within 28 days prior to screening;
- Other exclusion criteria set by protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai general hospital
Shanghai, Shanghai Municipality, P. R. China 200080
Xiaodong Sun, Doctor
About this study
Official title: An Open-label, Multicenter, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Intravitreal Injection of IBI302 in Participants With Neovascular Age-related Macular Degeneration
This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.
- Being tested
- IBI302 8mg dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI302 8mg doseDrug
8 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IBI302 8mg dose 8mg | Experimental | Drug: IBI302 8mg/Intravitreal injection Receives: Drug: IBI302 8mg dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters from baseline as measured by the visual acuity chart in the early treatment diabetic retinopathy study (ETDRS) at week 52
Measured: Week52
Secondary outcomes (13)
The changes in BCVA from baseline at each visit
Measured: Baseline，Weeks 4，8，12，16，20，24，28，32，36，40，44，48 and 52
Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52
Measured: Week52
Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52
Measured: Week52
The change in central subfield thickness of the macula measured by OCT from the baseline at week 52
Measured: Week52
Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52
Measured: Week52
Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseline
Measured: Week52
Change in CNV leakage area on FFA at week 52 compared to baseline
Measured: Week52
Proportion of participants with new-onset MA on OCT at Week 52
Measured: Week52
Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52
Measured: Week52
Change in MA area on OCT from baseline at Week 52
Measured: Week52
Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52
Measured: Week52
The incidence rate, correlation with the studied drugs, and severity of ocular and systemic adverse events (AE), treatment emergent adverse events (TEAE), and serious adverse events (SAE)
Measured: From baseline through Week 52
The production of anti-drug antibodies in the serum
Measured: Day0、Week4、Week16、Week32、Week48、Week52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start5 Dec 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275840
- Sponsor's protocol ID
- CIBI302A203
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 8 Jan 2026
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Intravitreal Injection of IBI302 in Participants With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07275840
- Acronym / sponsor ID
- CIBI302A203
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Innovent Biologics Technology Limited (Shanghai R&D Center)Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 10 Dec 2025 (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 Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI302 8mg dose 8mg | Experimental | Drug: IBI302 8mg doseDrug: IBI302 8mg/Intravitreal 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)
- Have signed an informed consent form before participating in the research.
- Male or female individuals aged 50 or above at the time of signing the informed consent form;
- Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea.
- At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).
Key exclusion criteria (10 listed)
- According to the investigator's judgment, concomitant ocular diseases/systemic diseases of the study eyes at screening or baseline may lead to participants' non-response to the study treatment or confuse the interpretation of the study results;
- The study eye has uncontrollable glaucoma;
- There is an active intraocular or periocular infection or inflammation in either eye;
- The non-study eye has severe visual function disorders;
- Within 90 days before baseline, the study eye had received anti-VEGF 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 |
|---|---|---|
| IBI302 8mg dose8 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks. | Drug | IBI302 8mg dose 8mg |
Primary outcome
Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters from baseline as measured by the visual acuity chart in the early treatment diabetic retinopathy study (ETDRS) at week 52
Time frame: Week52
13 secondary outcomes
The changes in BCVA from baseline at each visit
Time frame: Baseline，Weeks 4，8，12，16，20，24，28，32，36，40，44，48 and 52
Proportion of patients with BCVA improvement of ≥0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52
Time frame: Week52
Proportion of participants with a decrease in BCVA of >0, ≥5, ≥10, and ≥15 ETDRS letters from baseline at week 52
Time frame: Week52
The change in central subfield thickness of the macula measured by OCT from the baseline at week 52
Time frame: Week52
Proportion of participants with IRF/SRF/Pigment epithelial detachment (PED) on OCT at Week 52
Time frame: Week52
Change in choroidal neovascularization (CNV) area on fundus fluorescein angiography (FFA) at week 52 compared to baseline
Time frame: Week52
Change in CNV leakage area on FFA at week 52 compared to baseline
Time frame: Week52
Proportion of participants with new-onset MA on OCT at Week 52
Time frame: Week52
Proportion of new-onset fibrosis on color fundus photography (CFP) at Week 52
Time frame: Week52
Change in MA area on OCT from baseline at Week 52
Time frame: Week52
Change in fibrosis area and maximum lesion diameter on CFP from baseline at Week 52
Time frame: Week52
The incidence rate, correlation with the studied drugs, and severity of ocular and systemic adverse events (AE), treatment emergent adverse events (TEAE), and serious adverse events (SAE)
Time frame: From baseline through Week 52
The production of anti-drug antibodies in the serum
Time frame: Day0、Week4、Week16、Week32、Week48、Week52
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 8 Jan 2026.
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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.
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 IBI302 8mg dose in people with Neovascular Age-related Macular Degeneration, run by Innovent Biologics Technology Limited (Shanghai R&D Center) 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 10 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. 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?
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?
Contact Yating Liu (86 15821084695, yating.liu@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants whose best corrected visual acuity (BCVA) of the study eye decreased by less than 15 letters from baseline as measured by the visual acuity chart in the early treatment diabetic retinopathy study (ETDRS) at week 52 (time frame: Week52). 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 8 Jan 2026.