ESBA1008 Microvolume Study

February 25, 2016 updated by: Alcon Research

A Prospective, Two-Staged, Single-Masked Study to Evaluate the Effect of ESBA1008 Applied by Microvolume Injection or Infusion in Subjects With Exudative Age-Related Macular Degeneration

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: ESBA1008 solution
Intravitreal injection or infusion
Experimental: 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
Drug: ESBA1008 solution
Intravitreal injection or infusion
Experimental: 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
Drug: ESBA1008 solution
Intravitreal injection or infusion
Experimental: 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
Drug: ESBA1008 solution
Intravitreal injection or infusion
Active Comparator: Ranibizumab 0.5 mg in 50 μL
Cohorts 1-4: One intravitreal injection on Day 0, followed by another intravitreal injection on Day 28
Drug: Ranibizumab
Intravitreal injection
Other Names:
  • LUCENTIS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28
Time Frame: Baseline, Day 14, Day 28

A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline:

  • Greater than or equal to 4 letter gain in BCVA at Day 14
  • Greater than or equal to 4 letter gain in BCVA at Day 28
  • Greater than or equal to 80 micron decrease in CSFT at Day 14
  • Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis.
Baseline, Day 14, Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in BCVA, Cohort 1
Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in BCVA, Cohort 2
Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in BCVA, Cohort 3
Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in BCVA, Cohort 4
Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 1
Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 2
Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 3
Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
Change From Baseline in CSFT, Cohort 4
Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42, Day 56
CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.
Baseline, Day 7, Day 14, Day 28, Day 42, Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Project Group Leader, GCRA, Pharma, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

May 6, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-13-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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