ESBA1008 Microvolume Study

NCT ID: NCT01849692

Last Updated: 2016-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-01-31

Brief Summary

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).

Detailed 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.

Conditions

Exudative Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESBA1008 1.2 mg/10 μL

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

Group Type: EXPERIMENTAL

ESBA1008 solution

Intervention Type: DRUG

Intravitreal injection or infusion

ESBA1008 1 mg/8.3 μL

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

Group Type: EXPERIMENTAL

ESBA1008 solution

Intervention Type: DRUG

Intravitreal injection or infusion

ESBA1008 0.6 mg/10 μL

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

Group Type: EXPERIMENTAL

ESBA1008 solution

Intervention Type: DRUG

Intravitreal injection or infusion

ESBA1008 0.5 mg/8.3 μL

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

Group Type: EXPERIMENTAL

ESBA1008 solution

Intervention Type: DRUG

Intravitreal injection or infusion

Ranibizumab 0.5 mg in 50 μL

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

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

Intravitreal injection

Interventions

ESBA1008 solution

Intravitreal injection or infusion

Intervention Type: DRUG

Ranibizumab

Intravitreal injection

Intervention Type: DRUG

Other Intervention Names

LUCENTIS®

Eligibility Criteria

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)

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;

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Project Group Leader, GCRA, Pharma

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-13-001

Identifier Type: -

Identifier Source: org_study_id