ESBA1008 Microvolume Study

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

ESBA1008 solution

Ranibizumab

About this trial

This is an interventional treatment trial for Exudative Age-Related Macular Degeneration focused on measuring Exudative Age-Related Macular Degeneration, Wet AMD, Choroidal neovascularization (CNV), Vascular endothelial growth factor (VEGF)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

ESBA1008 1.2 mg/10 μL

ESBA1008 1 mg/8.3 μL

ESBA1008 0.6 mg/10 μL

ESBA1008 0.5 mg/8.3 μL

Ranibizumab 0.5 mg in 50 μL

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and 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.

Secondary Outcome Measures

Change From Baseline in BCVA, Cohort 1

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.

Change From Baseline in BCVA, Cohort 2

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.

Change From Baseline in BCVA, Cohort 3

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.

Change From Baseline in BCVA, Cohort 4

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.

Change From Baseline in CSFT, Cohort 1

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.

Change From Baseline in CSFT, Cohort 2

CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.

Change From Baseline in CSFT, Cohort 3

CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.

Change From Baseline in CSFT, Cohort 4

CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.

Full Information

NCT ID

NCT01849692

First Posted

May 6, 2013

Last Updated

February 25, 2016

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01849692

Brief Title

ESBA1008 Microvolume Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Exudative Age-Related Macular Degeneration

Keywords

Exudative Age-Related Macular Degeneration, Wet AMD, Choroidal neovascularization (CNV), Vascular endothelial growth factor (VEGF)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ESBA1008 1.2 mg/10 μL

Arm Type

Experimental

Arm Description

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

Arm Title

ESBA1008 1 mg/8.3 μL

Arm Type

Experimental

Arm Description

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

Arm Title

ESBA1008 0.6 mg/10 μL

Arm Type

Experimental

Arm Description

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

Arm Title

ESBA1008 0.5 mg/8.3 μL

Arm Type

Experimental

Arm Description

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

Arm Title

Ranibizumab 0.5 mg in 50 μL

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ESBA1008 solution

Intervention Description

Intravitreal injection or infusion

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Other Intervention Name(s)

LUCENTIS®

Intervention Description

Intravitreal injection

Primary Outcome Measure Information:

Title

Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28

Description

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.

Time Frame

Baseline, Day 14, Day 28

Secondary Outcome Measure Information:

Title

Change From Baseline in BCVA, Cohort 1

Description

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.

Time Frame