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Neovascular Age-related Macular DegenerationPhase 1NCT03814291

A Dose Escalation Study of IBI302 in Patients With Wet Age-related Macular Degeneration

A Phase 1 study testing IBI302 in people with Neovascular Age-related Macular Degeneration, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with wet AMD. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
IBI302
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
15 Apr 2019to 10 Apr 2020
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 CNV secondary to wet AMD, with lesion size ≤ 12 optic discs in the study eye.
  • BCVA score of 10-73 letters using ETDRS charts (in 4 meters) in the study eye.
  • Central macular sub-field thickness according to OCT of at least 250 micron.
  • Clear stereoscopic fundus photography is obtained while the lens or other media is clear.
  • Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 3 months after the end of treatment.
  • Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Who cannot join

  • Presence of other causes of CNV other than wet AMD in the study eye.
  • Presence of active diabetic retinopathy in the study eye.
  • Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment).
  • Prior retinal detachment in the study eye.
  • Prior any treatment of following in the study eye:
  • Anti-VEGF therapy within 6 months prior to screening;
Show all 27Show fewer
  • Anti-complement therapy;
  • Laser photocoagulation;
  • Photodynamic therapy;
  • Transpupillary thermotherapy
  • Intraocular surgery;
  • Intraocular or periocular glucocorticoid injection therapy within 6 months prior to enrollment;
  • Presence of any non-AMD disease that may affect visual acuity in the study eye
  • Prior anti-VEGF therapy within 1 month before study drug administration or plan of above anti-VEGF therapy in the non-study eye during the whole study.
  • Oral steroid drugs within 1 month before study drug administration.
  • Presence of active intraocular or periocular inflammation or infection.
  • Diabetic patients have any of the following conditions:
  • Microvascular and macrovascular complications;
  • HbA1c>7.5% when screening;
  • Receiving more than two oral hypoglycemic agents;
  • Receiving insulin or GLP-1 receptor agonist;
  • Hypertension (defined as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg despite standard treatment);
  • Presence of any following laboratory abnormality:
  • PLT<100×109/L, INR≥1.5ULN, APTT≥ 10 seconds more than ULN;
  • ALT or AST >2ULN;
  • Cr or Ur>1.5ULN;
  • Large or medium surgery, or unhealed surgical incisions, ulcers or fractures within 1 month before study drug administration.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

Other trials in China

About this study

Official title: A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI302 in Patients With Wet Age-related Macular Degeneration (AMD)

This study is designed for single-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with wet AMD.

Being tested
IBI302

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI302Drug

    0.05mg/eye;Intraocular injection

  • IBI302Drug

    0.15mg/eye;Intraocular injection

  • IBI302Drug

    0.5mg/eye;Intraocular injection

  • IBI302Drug

    1mg/eye;Intraocular injection

  • IBI302Drug

    2mg/eye;Intraocular injection

  • IBI302Drug

    4mg/eye;Intraocular injection

Study groups in NCT03814291
Study groupRoleWhat they receive
cohort 1 IBI302 treated with first dose level of IBI302ExperimentalNot described
Receives: Drug: IBI302
cohort 2 IBI302 treated with second dose level of IBI302ExperimentalNot described
Receives: Drug: IBI302
cohort 3 IBI302 treated with third dose level of IBI302ExperimentalNot described
Receives: Drug: IBI302
cohort 4 IBI302 treated with fourth dose level of IBI302ExperimentalNot described
Receives: Drug: IBI302
cohort 5 IBI302 treated with fifth dose level of IBI302ExperimentalNot described
Receives: Drug: IBI302
cohort 6 IBI302 treated with sixth dose level of IBI302ExperimentalNot described
Receives: Drug: IBI302

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety evaluation indicators

    Decreasing of BCVA; b) Changes in intraocular pressure compared with baseline; c) Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events;

    Measured: Baseline to Day43

Secondary outcomes (9)

  1. Efficacy evaluation indicators

    Changes in central subfield thickness by OCT compared with baseline; b) Changes in CNV area by FA compared with baseline; c) Changes in BCVA compared with baseline.

    Measured: Baseline to Day43

  2. Immunogenicity evaluation indicators

    Positive rate of anti-drug antibody and neutralizing antibody

    Measured: Baseline to Day43

  3. The area under the drug-time curve from 0 to time t (AUC0-t)

    Measured: Baseline to Day43

  4. The area under the curve at the time of 0-infinity (AUC0-∞)

    Measured: Baseline to Day43

  5. The peak concentration (Cmax)

    Measured: Baseline to Day43

  6. The peak time (Tmax)

    Measured: Baseline to Day43

  7. Clearance rate (CL)

    Measured: Baseline to Day43

  8. Half-life (t1/2)

    Measured: Baseline to Day43

  9. Free and total VEGF concentration

    Measured: Baseline to Day43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2019
  2. Study start15 Apr 2019
  3. Primary completion5 Mar 2020
  4. Study completion10 Apr 2020

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03814291
Sponsor's protocol ID
CIBI302A101
Status last verified
Apr 2025
First submitted
15 Jan 2019
Last updated
17 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yang S, Li T, Jia H, Gao M, Li Y, Wan X, Huang Z, Li M, Zhai Y, Li X, Yang X, Wang T, Liang J, Gu Q, Luo X, Qian L, Lu S, Liu J, Song Y, Wang F, Sun X, Yu D. Targeting C3b/C4b and VEGF with a bispecific fusion protein optimized for neovascular age-related macular degeneration therapy. Sci Transl Med. 2022 Jun;14(647):eabj2177. doi: 10.1126/scitranslmed.abj2177. Epub 2022 Jun 1.

    PubMed 35648811

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 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 7 inclusion and 27 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 17 Apr 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 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?

Safety evaluation indicators (time frame: Baseline to Day43). 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 NCT03814291, 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 17 Apr 2025.

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