Last updated: December 25, 2023
Sponsor: Innostellar Biotherapeutics Co.,Ltd
Overall Status: Active - Recruiting
Phase
2
Condition
Macular Degeneration
Geographic Atrophy
Treatment
Aflibercept intravitreal injection
LX102 subretinal injection
Clinical Study ID
NCT06196840
INNOSTELLAR-LX102A01-2
Ages 50-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Willing to sign the informed consent, and willing to attend follow-up visits.
- Age ≥ 50, and ≤ 89.
- Diagnosis of active CNV secondary to neovascular AMD.
- BCVA ETDRS letters between 19 and 73.
- 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.
- Absence of RPE tear at Screening.
- 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 ≥100mmHg.
- Uncontrolled diabetes defined as HbA1c >8.0%.
Study Design
Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Aflibercept intravitreal injection
Phase: 2
Study Start date:
December 21, 2023
Estimated Completion Date:
May 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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