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Trial record 1 of 1 for:    NCT01849692
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ESBA1008 Microvolume Study

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.
 
ClinicalTrials.gov Identifier: NCT01849692
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : February 25, 2016
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE May 6, 2013
First Posted Date  ICMJE May 8, 2013
Results First Submitted Date  ICMJE January 29, 2016
Results First Posted Date  ICMJE February 25, 2016
Last Update Posted Date March 24, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
Response based upon central subfield thickness (CSFT) and best-corrected visual acuity (BCVA) outcomes at Day 14 and Day 28 [ Time Frame: Baseline, up to Day 28 ]
A subject will be considered a responder if at least 3 out of the following 4 criteria are fulfilled in comparison to baseline:
  • Protocol-specified letter gain in BCVA at Day 14
  • Protocol-specified letter gain in BCVA at Day 28
  • Protocol-specified micron loss in CSFT at Day 14
  • Protocol-specified micron loss in CSFT at Day 28
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2013)
  • Change from baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, up to Day 56 ]
    As measured by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing
  • Change from baseline in Central Subfield Thickness (CSFT) [ Time Frame: Baseline, up to Day 56 ]
    As measured by Spectral-Domain Optical Coherence Tomography (SD-OCT)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ESBA1008 Microvolume Study
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Exudative Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: ESBA1008 solution
    Intravitreal injection or infusion
  • Drug: Ranibizumab
    Intravitreal injection
    Other Name: LUCENTIS®
Study Arms  ICMJE
  • 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
    Intervention: Drug: ESBA1008 solution
  • 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
    Intervention: Drug: ESBA1008 solution
  • 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
    Intervention: Drug: ESBA1008 solution
  • 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
    Intervention: Drug: ESBA1008 solution
  • 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
    Intervention: Drug: Ranibizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2015)
107
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2013)
26
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01849692
Other Study ID Numbers  ICMJE C-13-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Project Group Leader, GCRA, Pharma Alcon Research
PRS Account Alcon Research
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP