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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alcon Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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