Skip to main content
OpenTrials
Completed

NCT Number: NCT01849692

ESBA1008 Microvolume Study

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Exudative Age-Related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESBA1008 solution

Drug

Intravitreal injection or infusion

ranibizumab

Drug

Intravitreal injection

Other names: LUCENTIS®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 8, 2013
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.