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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01304693
First received: February 24, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Exudative Age-Related Macular Degeneration
Biological: ESBA1008 solution
Biological: Ranibizumab 0.5 mg
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of ESBA1008 Versus LUCENTIS® for the Treatment of Exudative Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Time to event, up to Month 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 376
Study Start Date: October 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESBA1008
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®

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).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304693

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Georges Weissgerber, MD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01304693     History of Changes
Other Study ID Numbers: C-10-083
Study First Received: February 24, 2011
Results First Received: April 7, 2014
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria : Federal Ministry for Labour, Health, and Social Affairs
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ethics Commission

Keywords provided by Alcon Research:
AMD
Wet AMD
Exudative
CNV

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 01, 2014