Back to resultsESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients
Primary Purpose
Exudative Age-Related Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ESBA1008 solution
Ranibizumab 0.5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Exudative Age-Related Macular Degeneration focused on measuring AMD, Wet AMD, Exudative, CNV
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent.
- Primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions, in the study eye.
- New diagnosis of wet AMD or evidence of recent disease progression within the last 3 months in study eye.
- Evidence of subretinal fluid or retinal cystic changes with a CSFT of > 340 μm using a Spectralis SD-OCT (Heidelberg Engineering) imaging system.
- Best-corrected visual acuity (BCVA) of Snellen equivalent 20/200 or better in the non-study eye.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Previously administered therapy, approved or investigational, for wet AMD in the study eye.
- Any current or history of macular or retinal disease in the stuy eye other than wet AMD.
- Lasik or cataract surgery within the last 3 months in the study eye or expected to have cataract removal surgery during the study.
- Uncontrolled or advanced glaucoma in the study eye.
- Use of systemic or topical ocular corticosteroids.
- History of a medical condition that, in the opinion of the Investigator, would preclude scheduled visits, completion of the study, or safe administration of study medication.
- Abnormal or unsuitable laboratory results at Screening visit.
- Lactating or pregnant. Women of childbearing potential must use adequate birth control for the duration of the study.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ESBA1008
LUCENTIS
Arm Description
ESBA1008 solution, single intravitreal injection
Ranibizumab 0.5 mg, single intravitreal injection
Outcomes
Primary Outcome Measures
Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)
CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.
Secondary Outcome Measures
Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria
Standard of care (SOC) therapy for exudative AMD was implemented if any protocol-specified criteria relating to CSFT, best-corrected visual acuity, or clinically significant intraocular hemorrhages in the study eye were met, in the opinion of the Investigator.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01304693
Brief Title
ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients
Official Title
Safety and Efficacy Study of ESBA1008 Versus LUCENTIS® for the Treatment of Exudative Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (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 was to assess the safety, tolerability, and the effects of treatment on ocular outcomes following a single intravitreal administration of ESBA1008 compared with LUCENTIS® in patients with exudative age-related macular degeneration (AMD).
Detailed Description
This study was conducted in two parts. In Part 1, patients were initially randomized (5:2) to receive either ESBA1008 at the lowest dose (Dose A) or LUCENTIS. After Safety Committee review, a second cohort was enrolled and randomized (5:2) to the next higher dose of ESBA1008 (Dose B). Safety review and enrollment of patients into the third cohort (Dose C) and fourth cohort (Dose D) was conducted in the same manner. Part 2, the expansion period, consisted of 2 arms. In the first arm patients were randomized to receive ESBA1008 Dose C or LUCENTIS (43:44) . In the second arm, patients were randomized to ESBA1008 Doses A:B:D:Lucentis (5:30:35:9). All enrolled patients (Part 1 and Part 2) were evaluated for safety and efficacy across 13 study visits, including Screening, Randomization, and 11 post- treatment follow-up visits (Day 1 through Month 6).
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
AMD, Wet AMD, Exudative, CNV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
376 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ESBA1008
Arm Type
Experimental
Arm Description
ESBA1008 solution, single intravitreal injection
Arm Title
LUCENTIS
Arm Type
Active Comparator
Arm Description
Ranibizumab 0.5 mg, single intravitreal injection
Intervention Type
Biological
Intervention Name(s)
ESBA1008 solution
Intervention Description
Administered as a single intravitreal injection (Dose A, Dose B, Dose C, Dose D)
Intervention Type
Biological
Intervention Name(s)
Ranibizumab 0.5 mg
Other Intervention Name(s)
LUCENTIS®
Intervention Description
Administered as a single intravitreal injection
Primary Outcome Measure Information:
Title
Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)
Description
CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.
Time Frame
Baseline, Month 1
Secondary Outcome Measure Information:
Title
Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria
Description
Standard of care (SOC) therapy for exudative AMD was implemented if any protocol-specified criteria relating to CSFT, best-corrected visual acuity, or clinically significant intraocular hemorrhages in the study eye were met, in the opinion of the Investigator.
Time Frame
Time to event, up to Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent.
Primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions, in the study eye.
New diagnosis of wet AMD or evidence of recent disease progression within the last 3 months in study eye.
Evidence of subretinal fluid or retinal cystic changes with a CSFT of > 340 μm using a Spectralis SD-OCT (Heidelberg Engineering) imaging system.
Best-corrected visual acuity (BCVA) of Snellen equivalent 20/200 or better in the non-study eye.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Previously administered therapy, approved or investigational, for wet AMD in the study eye.
Any current or history of macular or retinal disease in the stuy eye other than wet AMD.
Lasik or cataract surgery within the last 3 months in the study eye or expected to have cataract removal surgery during the study.
Uncontrolled or advanced glaucoma in the study eye.
Use of systemic or topical ocular corticosteroids.
History of a medical condition that, in the opinion of the Investigator, would preclude scheduled visits, completion of the study, or safe administration of study medication.
Abnormal or unsuitable laboratory results at Screening visit.
Lactating or pregnant. Women of childbearing potential must use adequate birth control for the duration of the study.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges Weissgerber, MD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients
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