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Completed

NCT Number: NCT01269151

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

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Function

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Luebeck - Department of Ophthalmology

Lübeck, 23538, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Systemic conditions or treatments

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

Ocular concomitant conditions/ diseases

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

Compliance/ Administrative

  • 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.
  • Patients will be excluded who were younger than 50 years according of the definition of age-related AMD.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
  • Pregnant or nursing (lactating) women
  • Inability to comply with study or follow-up procedures.
  • Any treatment with an investigational agent in the past 3 months any condition.

Treatment and study plan

Lucentis (Ranibizumab)

Drug

Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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,

  2. to document changes in angiography

    Time frame: 12 months

    to document changes in angiography

  3. to document changes in optical coherence tomography (OCT)

    Time frame: 12 months

    to document changes in optical coherence tomography (OCT)

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Official study 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

Acronym: LucERG

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jan 4, 2011
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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