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

Neovascular Age-related Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03814291
• Other study ID #: CIBI302A101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 16, 2019
• Est. completion date: April 5, 2020

Study information

• Verified date: February 2020
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: April 5, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patient = 50 yrs. of age.

2. Active subfoveal CNV secondary to wet AMD, with lesion size = 12 optic discs in the study eye.

3. BCVA score of 10-73 letters using ETDRS charts (in 4 meters) in the study eye.

4. Central macular sub-field thickness according to OCT of at least 250 micron.

5. Clear stereoscopic fundus photography is obtained while the lens or other media is clear.

6. 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.

7. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion Criteria:

1. Presence of other causes of CNV other than wet AMD in the study eye.

2. Presence of active diabetic retinopathy in the study eye.

3. Presence of uncontrolled glaucoma in the study eye (defined as IOP=30mmHg despite the standardized treatment).

4. Prior retinal detachment in the study eye.

5. Prior any treatment of following in the study eye:

1. Anti-VEGF therapy within 6 months prior to screening;

2. Anti-complement therapy;

3. Laser photocoagulation;

4. Photodynamic therapy;

5. Transpupillary thermotherapy

6. Intraocular surgery;

7. Intraocular or periocular glucocorticoid injection therapy within 6 months prior to enrollment;

6. Presence of any non-AMD disease that may affect visual acuity in the study eye

7. 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.

8. Oral steroid drugs within 1 month before study drug administration.

9. Presence of active intraocular or periocular inflammation or infection.

10. Diabetic patients have any of the following conditions:

1. Microvascular and macrovascular complications;

2. HbA1c>7.5% when screening;

3. Receiving more than two oral hypoglycemic agents;

4. Receiving insulin or GLP-1 receptor agonist;

11. Hypertension (defined as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg despite standard treatment);

12. Presence of any following laboratory abnormality:

1. PLT<100×109/L, INR=1.5ULN, APTT= 10 seconds more than ULN;

2. ALT or AST >2ULN;

3. Cr or Ur>1.5ULN;

13. Large or medium surgery, or unhealed surgical incisions, ulcers or fractures within 1 month before study drug administration.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration

Intervention

Drug:
• IBI302
0.05mg/eye;Intraocular injection
• IBI302
0.15mg/eye;Intraocular injection
• IBI302
0.5mg/eye;Intraocular injection
• IBI302
1mg/eye;Intraocular injection
• IBI302
2mg/eye;Intraocular injection
• IBI302
4mg/eye;Intraocular injection

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to Day43
Secondary	Immunogenicity evaluation indicators	Positive rate of anti-drug antibody and neutralizing antibody	Baseline to Day43
Secondary	The area under the drug-time curve from 0 to time t (AUC0-t)		Baseline to Day43
Secondary	The area under the curve at the time of 0-infinity (AUC0-8)		Baseline to Day43
Secondary	The peak concentration (Cmax)		Baseline to Day43
Secondary	The peak time (Tmax)		Baseline to Day43
Secondary	Clearance rate (CL)		Baseline to Day43
Secondary	Half-life (t1/2)		Baseline to Day43
Secondary	Free and total VEGF concentration		Baseline to Day43