Status:
COMPLETED
A Dose Escalation Study of IBI302 in Patients With Wet Age-related Macular Degeneration
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03814291
Start Date
April 15 2019
End Date
April 10 2020
Last Update
April 17 2025
Active Locations (1)
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1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080