ESBA1008 Microvolume Study

Alcon

Status and phase: Completed; Phase 2

Conditions: Exudative Age-Related Macular Degeneration

Treatments: Drug: Ranibizumab; Drug: ESBA1008 solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01849692

C-13-001

Details and patient eligibility

About

The purpose of this study is to demonstrate a treatment effect of ESBA1008 applied as a microvolume injection or infusion on retinal function and morphology in subjects with exudative age-related macular degeneration (AMD).

Full description

This 4-cohort study was conducted in 2 stages. Stage 1 consisted out of 2 Cohorts. In each cohort subjects were randomized 10:3 to either receive ESBA1008 (Cohort 1 : 2 injections, Cohort 2 : 1 infusion and 1 injection) or 2 Lucentis injections. Stage 2 was conducted similarly with a different dosing level for ESBA1008 (Cohort 3 and 4). Subjects had follow-up visits at Day 7 and Day 14. All cohorts receiving ESBA1008 on Day 0 also received ESBA1008 6mg/50 μL via injection on Day 28. After the Day 28 visit (all cohorts), subjects returned for follow up visits at Day 42 and Day 56.

Enrollment: 107 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign informed consent document;
• Able to make the required study visits and follow instructions;
• Age-related macular degeneration in the study eye;
• Visual acuity within protocol-specified range;
• 340 μm minimal central subfield thickness (CSFT; Spectralis Equivalent)
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Both eyes: Any active infection or inflammation;
• Study eye: Any treatment for exudative age-related macular degeneration (AMD) other than vitamin supplements;
• Study eye: Any current or history of macular or retinal disease;
• Study eye: Any concurrent intraocular condition such as cataract or diabetic retinopathy that, in the opinion of the Investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss;
• Study eye: Other ocular conditions or diseases that, in the opinion of the Investigator, could compromise visual acuity;
• Study Eye: Uncontrolled glaucoma;
• History of a medical condition that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product;
• Women of childbearing potential who are lactating, pregnant, planning to become pregnant, or not using adequate birth control methods for the duration of the study;
• Intraocular surgery within 3 months of baseline;
• Study eye: Any history or current evidence of retinal angiomatous proliferation (RAP) lesions based on clinical exam;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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107 participants in 5 patient groups

ESBA1008 1.2 mg/10 μL

Experimental group

Description:

Cohort 1: One intravitreal injection on Day 0, followed by one intravitreal (IVT) injection of ESBA1008 6 mg/50 μL on Day 28

Treatment:

Drug: ESBA1008 solution

ESBA1008 1 mg/8.3 μL

Experimental group

Description:

Cohort 2: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28

Treatment:

Drug: ESBA1008 solution

ESBA1008 0.6 mg/10 μL

Experimental group

Description:

Cohort 3: One intravitreal injection on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28

Treatment:

Drug: ESBA1008 solution

ESBA1008 0.5 mg/8.3 μL

Experimental group

Description:

Cohort 4: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28

Treatment:

Drug: ESBA1008 solution

Ranibizumab 0.5 mg in 50 μL

Active Comparator group

Description:

Cohorts 1-4: One intravitreal injection on Day 0, followed by another intravitreal injection on Day 28

Treatment:

Drug: Ranibizumab