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

NCT03814291 | Completed Phase 1

• 1 other identifier: CIBI302A101
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (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;

  Baseline to Day43

Secondary Outcomes (9)

• Efficacy evaluation indicators

  Baseline to Day43

• Immunogenicity evaluation indicators

  Baseline to Day43

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

  Baseline to Day43

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

  Baseline to Day43

• The peak concentration (Cmax)

  Baseline to Day43

Study Arms (6)

cohort 1 IBI302 treated with first dose level of IBI302

EXPERIMENTAL

Drug: IBI302

cohort 2 IBI302 treated with second dose level of IBI302

EXPERIMENTAL

Drug: IBI302

cohort 3 IBI302 treated with third dose level of IBI302

EXPERIMENTAL

Drug: IBI302

cohort 4 IBI302 treated with fourth dose level of IBI302

EXPERIMENTAL

Drug: IBI302

cohort 5 IBI302 treated with fifth dose level of IBI302

EXPERIMENTAL

Drug: IBI302

cohort 6 IBI302 treated with sixth dose level of IBI302

EXPERIMENTAL

Drug: IBI302

Interventions

IBI302 DRUG

0.05mg/eye;Intraocular injection

cohort 1 IBI302 treated with first dose level of IBI302

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (1)

• 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.

  PMID: 35648811 DERIVED

MeSH Terms

Interventions

IBI302

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 24, 2019
• Study Start: April 15, 2019
• Primary Completion: March 5, 2020
• Study Completion: April 10, 2020
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

CN (1)