ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients
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|ClinicalTrials.gov Identifier: NCT01304693|
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : May 7, 2014
Last Update Posted : July 17, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Exudative Age-Related Macular Degeneration||Biological: ESBA1008 solution Biological: Ranibizumab 0.5 mg||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||376 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Safety and Efficacy Study of ESBA1008 Versus LUCENTIS® for the Treatment of Exudative Age-Related Macular Degeneration|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
ESBA1008 solution, single intravitreal injection
Biological: ESBA1008 solution
Administered as a single intravitreal injection (Dose A, Dose B, Dose C, Dose D)
Active Comparator: LUCENTIS
Ranibizumab 0.5 mg, single intravitreal injection
Biological: Ranibizumab 0.5 mg
Administered as a single intravitreal injection
Other Name: LUCENTIS®
- Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT) [ Time Frame: Baseline, Month 1 ]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.
- Duration of Effect Measured by the Time From Randomization to Receipt of Standard of Care as Determined by the Investigator Based on Protocol Criteria [ Time Frame: Time to event, up to Month 6 ]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.
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|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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): NCT01304693
|Study Director:||Georges Weissgerber, MD||Alcon Research|
|Responsible Party:||Alcon Research|
|Other Study ID Numbers:||
|First Posted:||February 25, 2011 Key Record Dates|
|Results First Posted:||May 7, 2014|
|Last Update Posted:||July 17, 2014|
|Last Verified:||July 2014|
Wet Macular Degeneration
Angiogenesis Modulating Agents
Physiological Effects of Drugs