Ranibizumab Short- and Log-term Effects on Retinal Function in wAMD (LucERG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Matthias Lueke, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01269151
First received: January 3, 2011
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

Multifocal-electroretinoram (ERG) and microperimetry are objective criteria to asses retinal function. No information besides visual acuity exist for the development of retinal function during the course of wet AMD during therapy with Lucentis. The aim of our study is to evaluate the value of multifocal-ERG and microperimetry as an sensitive tool and early predictor of recurrence of the disease. The second goal will be to evaluate the neuroprotective effects of an adequate therapy on retinal function using microperimetry and multifocal-ERG during the course of wet AMD.


Condition Intervention
Age-Related Macular Degeneration
Retinal Function
Drug: Lucentis (Ranibizumab)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective, Non-randomized, Mono-center, Cohort Study to Evaluate the Short- and Long-term Effects of 0.5mg Intraocular Ranibizumab (Lucentis) Injections on Retinal Function in Patients With Wet Age-related Macular Degeneration During Twelve Month

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.


Secondary Outcome Measures:
  • to document changes in best corrected visual acuity (BCVA) measured on 4 meters, [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    to document changes in best corrected visual acuity (BCVA) measured on 4 meters,

  • to document changes in angiography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    to document changes in angiography

  • to document changes in optical coherence tomography (OCT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    to document changes in optical coherence tomography (OCT)


Enrollment: 20
Study Start Date: October 2010
Study Completion Date: April 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lucentis (Ranibizumab) Drug: Lucentis (Ranibizumab)
Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients above 50 years of age
  2. wet age-related macular degeneration (AMD)
  3. an available follow-up of 12 months
  4. written informed consent
  5. visual acuity of 0.1 or better

Exclusion Criteria:

Systemic conditions or treatments

  1. history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
  2. clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within the last 6 months
  3. ventricular tachyarrythmias requiring ongoing treatment
  4. History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
  5. Clinically significant impaired renal or hepatic function
  6. Stroke within 12 month before trial entry.
  7. Known serious allergies to the fluorescein dye use in angiography
  8. Known contraindications to the components of Lucentis® formulation.

Ocular concomitant conditions/ diseases

  1. Active intraocular inflammation (grade trace or above) in either eye
  2. Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
  3. History of uveitis in either eye
  4. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, etc.) or intravitreal corticosteroids in either eye within 3 months prior to inclusion
  5. Angle block glaucoma
  6. Phthisis
  7. Intraocular Pressure <10mmHg
  8. Macular or retinal dystrophies

Compliance/ Administrative

  1. Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to inclusion.
  2. Patients will be excluded who were younger than 50 years according of the definition of age-related AMD.
  3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
  4. Pregnant or nursing (lactating) women
  5. Inability to comply with study or follow-up procedures.
  6. Any treatment with an investigational agent in the past 3 months any condition.
  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: NCT01269151

Locations
Germany
University of Luebeck - Department of Ophthalmology
Lübeck, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Investigators
Principal Investigator: Salvatore Grisanti, M.D. Prof. University of Luebeck - Department of Ophthalmology: Germany
  More Information

No publications provided

Responsible Party: Dr. Matthias Lueke, Dr. med. Matthias Lüke, University of Luebeck
ClinicalTrials.gov Identifier: NCT01269151     History of Changes
Other Study ID Numbers: LucERG-001
Study First Received: January 3, 2011
Last Updated: May 14, 2014
Health Authority: Ethics Committee of the University of Luebeck: Germany
Paul-Ehrlich-Institut (PEI): Germany

Keywords provided by University of Luebeck:
Age-Related Macular Degeneration
Retinal Function
multifocal-ERG
Electroretinography
microperimetry
Lucentis
Ranibizumab
longterm effects
best corrected visual acuity
BCVA

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

ClinicalTrials.gov processed this record on October 21, 2014