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

NCT01304693 | Completed Phase 1 Results

• 1 other identifier: C-10-083
• Study Type: interventional
• Target: 376
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Exudative Age-Related Macular Degeneration

Keywords

AMD; Wet AMD; Exudative; CNV

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Month 1

Secondary Outcomes (1)

• 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

Study Arms (2)

ESBA1008

EXPERIMENTAL

ESBA1008 solution, single intravitreal injection

Biological: ESBA1008 solution

LUCENTIS

ACTIVE COMPARATOR

Ranibizumab 0.5 mg, single intravitreal injection

Biological: Ranibizumab 0.5 mg

Interventions

ESBA1008 solution BIOLOGICAL

Administered as a single intravitreal injection (Dose A, Dose B, Dose C, Dose D)

ESBA1008

Ranibizumab 0.5 mg BIOLOGICAL

Administered as a single intravitreal injection

Also known as: LUCENTIS®

LUCENTIS

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Georges Weissgerber, Executive Director, Novartis Pharma AG
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Georges Weissgerber, MD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: February 25, 2011
• Study Start: October 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 17, 2014
• Results First Posted: May 7, 2014

Record last verified: 2014-07