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ESBA1008 Microvolume Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01849692
First Posted: May 8, 2013
Last Update Posted: March 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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).

Condition Intervention Phase
Exudative Age-Related Macular Degeneration Drug: ESBA1008 solution Drug: Ranibizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 107
Study Start Date: June 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: LUCENTIS®

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849692


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Clinical Project Group Leader, GCRA, Pharma Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01849692     History of Changes
Other Study ID Numbers: C-13-001
First Submitted: May 6, 2013
First Posted: May 8, 2013
Results First Submitted: January 29, 2016
Results First Posted: February 25, 2016
Last Update Posted: March 24, 2016
Last Verified: January 2016

Keywords provided by Alcon Research:
Exudative Age-Related Macular Degeneration
Wet AMD
Choroidal neovascularization (CNV)
Vascular endothelial growth factor (VEGF)

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents