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

NCT ID: NCT01304693

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-03-31

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).

Conditions

Exudative Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ESBA1008

ESBA1008 solution, single intravitreal injection

Group Type: EXPERIMENTAL

ESBA1008 solution

Intervention Type: BIOLOGICAL

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

LUCENTIS

Ranibizumab 0.5 mg, single intravitreal injection

Group Type: ACTIVE_COMPARATOR

Ranibizumab 0.5 mg

Intervention Type: BIOLOGICAL

Administered as a single intravitreal injection

Interventions

ESBA1008 solution

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

Intervention Type: BIOLOGICAL

Ranibizumab 0.5 mg

Administered as a single intravitreal injection

Intervention Type: BIOLOGICAL

Other Intervention Names

LUCENTIS®

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.

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Georges Weissgerber, MD

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-10-083

Identifier Type: -

Identifier Source: org_study_id