Text Size

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: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety, tolerability and effects of an investigational drug ESBA1008 for the treatment of exudative age-related macular degeneration


Condition Intervention Phase
Exudative Age-related Macular Degeneration
 Biological: ESBA1008
Biological: Ranibizumab
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • The incidence of targeted adverse events that occur in the study eye within 7 days of the intravitreal injection [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in central subfield thickness [ Time Frame: Week 2, Month 1 ] [ Designated as safety issue: No ]
  • Change from baseline in best-corrected visual acuity [ Time Frame: Day 1, Week 1&2, Month 1 ] [ Designated as safety issue: Yes ]

Enrollment: 376
Study Start Date: July 2011
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 for intravitreal injection
 Biological: ESBA1008
ESBA1008 solution for intravitreal injection
Active Comparator: Lucentis
Lucentis 0.5 mg intravitreal injection
 Biological: Ranibizumab
Lucentis 0.5 mg

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions in study eye
  • a new diagnosis of exudative AMD or evidence of recent disease progression within the last 3 months in study eye

Exclusion Criteria:

  • Study eye must not have been treated for wet AMD previously
  • Study eye must not have any other ocular disease, condition, infection or recent surgery that would interfere with vision or examination of the back of the eye
  • Study eye must not have uncontrolled glaucoma and/or must not be missing a lens
  • Current use or history of chronic therapy with systemic or topical ocular corticosteroids
  • Must not have medical condition that would preclude scheduled study visits, completion of study or safe administration of study medication
  • Must not have allergies to any component of the test article or sensitivity to fluorescein dye
  • Abnormal screening laboratory result
  • Female of childbearing potential who are not using adequate birth control methods.
  Contacts and Locations
No Contacts or Locations Provided
  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
Last Updated: April 18, 2013
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)

Keywords provided by Alcon Research:
age-related macular degeneration
exudative
CNV

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

ClinicalTrials.gov processed this record on May 16, 2013