By InvitationPhase 1

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

China18 participantsStarted 2025-04-22

Plain-language summary

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

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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：

Incidence of DLTs

Timeframe: 4 weeks

Incidence of AEs

Timeframe: 52 weeks

Incidence of SAEs

Timeframe: 52 weeks

NCT IDNCT06737354

SponsorInnoVec Biotherapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Who can participate

Age range50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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：