ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients

Phase 1

Completed

• Conditions: Exudative Age-Related Macular Degeneration
• Interventions: Biological: Ranibizumab 0.5 mg; Biological: ESBA1008 solution

• Registration Number: NCT01304693
• Lead Sponsor: Alcon Research

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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-04-07
• Results First Submitted QC: 2014-04-07
• Results First Posted: 2014-05-07
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LUCENTIS	Ranibizumab 0.5 mg	Ranibizumab 0.5 mg, single intravitreal injection
ESBA1008	ESBA1008 solution	ESBA1008 solution, single intravitreal injection

Primary Outcome Measures

Name	Time	Method
Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT)	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.

Secondary Outcome Measures

Name	Time	Method
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 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.