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A Study of IBI302 in Patients With nAMD

Sponsor
Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04820452
Collaborator
(none)
231
Enrollment
1
Location
3
Arms
25.1
Anticipated Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is designed for multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of IBI302 in subjects with neovascular age-related macular degeneration.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
231 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Randomized, Double-blind, Active-controlled Phase II Study to Evaluate the Efficacy and Safety of IBI302 in Subjects With Neovascular Age-related Macular Degeneration
Actual Study Start Date :
Apr 28, 2021
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: cohort 1 IBI302 treated with high dose level of IBI302

Drug: IBI302 4mg/eye;Intraocular injection

Biological: High dose IBI302
High dose IBI302 intravitreal injection given as every other month after three loading monthly injection
Active Comparator: Aflibercept

Drug: Aflibercept 2mg/eye;Intraocular injection

Drug: Aflibercept
Intraocular injection
Experimental: cohort 1 IBI302 treated with low dose level of IBI302

Drug: IBI302 2mg/eye;Intraocular injection

Biological: Low dose IBI302
Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection

Outcome Measures

Primary Outcome Measures

  1. The visual efficacy of IBI302 [Baseline to week 36]

Secondary Outcome Measures

  1. other visual effects of IBI302 [Baseline to week 52]

    the proportion if BCVA improvement ≥0,5,10 or 15 letters at week 12, 28, 36 and 52.

  2. the anatomical effects of IBI302 on OCT [Baseline to week 52]

    the mean change of central subfield thickness from BL to week 52 at week 12, 28, 36 and 52

  3. the anatomical effects of IBI302 on FFA [Baseline to week 52]

    the change of CNV area, CNV leakage area, total lesion area from BL to week 36 or 52

  4. the safety of IBI302 [Baseline to week 52]

    the incidence of ocular AE or any systemic AE, TEAE, SAE

  5. Immunogenicity of IBI302 [Baseline to week 52]

    the positive rate of anti-drug antibody and neutralizing antibody

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion criteria

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

  2. Active subfoveal or parafoveal CNV secondary to neovascular AMD.

  3. BCVA score of 24-73 letters using ETDRS charts in the study eye.

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

Exclusion criteria

  1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;

  2. Presence of uncontrolled glaucoma in the study eye (defined as IOP≥25mmHg despite the standardized treatment);

  3. Presence of active intraocular or periocular inflammation or infection;

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

  5. Anti-VEGF therapy or anti-complement therapy within 3 months prior to screening;

  6. Laser photocoagulation within 3 months prior to screening;

  7. Photodynamic therapy or vitreoretinal surgery;

  8. Intraocular glucocorticoid injection within 6 months prior to enrollment;

  9. Presence of any systemic disease: including but not limited toactive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;

  10. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;

  11. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;

  12. Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;

  13. Other conditions unsuitable for enrollment judged by investigators

Contacts and Locations

Locations

Site City State Country Postal Code
1 Innovent Biologics (Suzhou) Co,Ltd. Suzhou Jiangsu China 215123

Sponsors and Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier:
NCT04820452
Other Study ID Numbers:
  • CIBI302A201
First Posted:
Mar 29, 2021
Last Update Posted:
Feb 28, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Aflibercept

Study Results

No Results Posted as of Feb 28, 2022