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

April 7, 2015 updated by: Dr. Matthias Lueke, University of Luebeck

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lübeck, Germany, 23538
        • University of Luebeck - Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lucentis (Ranibizumab)
Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.
Time Frame: 12 months
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to document changes in optical coherence tomography (OCT)
Time Frame: 12 months
to document changes in optical coherence tomography (OCT)
12 months
to document changes in best corrected visual acuity (BCVA) measured on 4 meters,
Time Frame: 12 months
to document changes in best corrected visual acuity (BCVA) measured on 4 meters,
12 months
to document changes in angiography
Time Frame: 12 months
to document changes in angiography
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Salvatore Grisanti, M.D. Prof., University of Luebeck - Department of Ophthalmology: Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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