Last updated: January 8, 2024
Sponsor: Innostellar Biotherapeutics Co.,Ltd
Overall Status: Active - Recruiting
Phase
1
Condition
Geographic Atrophy
Macular Degeneration
Treatment
LX102 subretinal injection
Clinical Study ID
NCT06198413
INNOSTELLAR-LX102A01-1
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Willing to sign the informed consent, and willing to attend follow-up visits.
- Age ≥ 50
- Diagnosis of active CNV secondary to neovascular AMD
- BCVA ETDRS letters between 5 and 63
- Subjects must have received a minimum of 2 injections within 6 months prior toscreening
- Demonstrated a meaningful response to anti-VEGF therapy
Exclusion
Exclusion Criteria:
- CNV or macular edema in the study eye secondary to diseases other than nAMD
- Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any conditionpreventing visual acuity improvement
- Acute coronary syndrome, myocardial infarction or coronary artery revascularization,CVA, TIA in the last 6 months
- Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
- Uncontrolled diabetes defined as HbA1c >7.5%
Study Design
Total Participants: 12
Treatment Group(s): 1
Primary Treatment: LX102 subretinal injection
Phase: 1
Study Start date:
February 27, 2023
Estimated Completion Date:
January 31, 2029
Study Description
Connect with a study center
Anhui Provincial Hospital
Hefei, Anhui
ChinaActive - Recruiting
Zhejiang University Eye Hospital
Hangzhou, Zhejiang
ChinaActive - Recruiting
Shanghai General Hospital
Shanghai,
ChinaActive - Recruiting
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