Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).

NCT06737354 | Enrolling By Invitation Phase 1 DMC FDA Drug

• 1 other identifier: IVB103-C101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety and efficacy of IVB103 injection in subjects with nAMD.

Conditions

nAMD

Keywords

nAMD; Retinal Disease

Outcome Measures

Primary Outcomes (3)

• Incidence of DLTs

  Number and proportion of dose limited toxicity（DLTs）

  4 weeks

• Incidence of AEs

  Number and severity of overall and ocular Adverse Events (AEs)

  52 weeks

• Incidence of SAEs

  Number and severity of overall and ocular Serious Adverse Events (SAEs)

  52 weeks

Secondary Outcomes (4)

• Visual function

  52 weeks

• OCT imaging

  52 weeks

• the number of anti-VEGF remedy therapy

  52 weeks

• mean annualized anti-VEGF injection rate

  52 weeks

Study Arms (3)

IVB103 Treatment Arm（Low dose）

EXPERIMENTAL

Intraocular injection of a single low dose of IVB103

Genetic: IVB103 Injection（Low dose）

IVB103 Treatment Arm（Intermediate dose）

EXPERIMENTAL

Intraocular injection of a single intermediate dose of IVB103

Genetic: IVB103 Injection（Intermediate dose）

IVB103 Treatment Arm（High dose）

EXPERIMENTAL

Intraocular injection of a single high dose of IVB103

Genetic: IVB103 Injection（High dose）

Interventions

IVB103 Injection（Low dose） GENETIC

Single intravitreal injection

IVB103 Treatment Arm（Low dose）

IVB103 Injection（Intermediate dose） GENETIC

Single intravitreal injection

IVB103 Treatment Arm（Intermediate dose）

IVB103 Injection（High dose） GENETIC

Single intravitreal injection

IVB103 Treatment Arm（High dose）

Eligibility Criteria

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

You may qualify if:

• Subjects voluntarily participate and sign the informed consent form;
• Age≥ 50 years old, gender is not limited;
• Confirmed presence of active CNV secondary to nAMD in the macula of study eye;
• The total area of all types of lesions in the study eye \< 30 mm2;
• The Best Corrected Visual Acuity (BCVA) detected by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart in the study eye is 63\~19 letters (including boundary values), which is equivalent to 20/63 to 20/400 of the Snellen Eye Chart;
• The BCVA detected by the ETDRS eye chart in the non-study eye is not less than 19 letters, which is equivalent to 20/400 of the Snellen Eye Chart;
• The study eye has received at least 2 episodes of intravitreal anti- VEGF therapy within 6 months prior to screening and has responded within two weeks of the lead-in period of anti-VEGF standard therapy (Aflibercept injection);
• At screening, the blood pregnancy test result of females of childbearing potential (e.g., females who have not undergone surgical sterilization or less than 1 year after menopause) is negative. Male and female subjects of childbearing potential agree to use effective contraception throughout the study and for at least 12 months after dosing.

You may not qualify if:

• Study Eye：
• Opacity of refractive media or inability to dilate pupils in the study eye that significantly interferes with visual acuity detection, anterior segment or fundus assessment;
• Presence of retinal hemorrhage, geographic atrophy, scarring or fibrosis, dense subfoveal hard exudate, retinal pigment epithelium (RPE) tear involving the fovea in the study eye;
• The study eye is combined with ocular diseases that affect central vision (e.g., diabetic retinopathy, retinal vein occlusion, vascular streaks, pathological myopia, retinal detachment, macular hole, epimacular membrane, toxoplasmosis, optic nerve disease, central serous choroidopathy, Inherited Retinal Diseases(IRDs), etc.);
• Active intraocular or periocular infection (such as blepharitis, conjunctivitis, keratitis, scleritis, etc.) in the study eye;
• Patients with glaucoma and ocular hypertension (intraocular pressure ≥ 25mmHg during the screening period) in the study eye;
• Subjects with a history of intravitreal procedures other than anti- VEGF administration within the last six months (e.g., vitrectomy, macular translocation, trabecular meshwork removal, or other filtration surgery;
• History of laser or photodynamic therapy for nAMD;
• Presence of an ocular implant in the study eye (excluding intraocular lens, custom flex iris prosthesis); Either eye：
• History of uveitis in either eye; Systemic diseases and others：
• Those with diffuse intravascular coagulation and obvious bleeding tendency (such as hemoptysis, hematemesis, severe purpura, etc.) within 3 months before screening;
• History of myocardial infarction, unstable angina, coronary revascularization, cerebrovascular accident (including TIA), history of other thromboembolic diseases (such as thromboembolic angiitis, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, etc.), New York Heart Association (NYHA) grade ≥ II cardiac insufficiency, severe unstable ventricular arrhythmia, within 6 months prior to screening;
• Have contraindications to transient immunosuppression of systemic prophylaxis (including but not limited to tuberculosis, osteoporosis, peptic ulcer, severe affective disorder) or immunocompromised;
• Patients with systemic immune diseases (including systemic lupus erythematosus, ankylosing spondylitis, rheumatoid arthritis, etc.);
• Diabetic patients with any of the following conditions: Known macrovascular complications; Glycosylated hemoglobin at screening（HbA1c）\>7.5%; Those who have received more than two oral hypoglycemic drugs or received insulin or GLP-1 receptor agonists therapies;

Sponsors & Collaborators

• InnoVec Biotherapeutics Inc.: lead
• NeoVec Biotherapeutics Inc.: collaborator

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 17, 2024
• Study Start: April 22, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)