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OpenTrials
Completed

NCT Number: NCT01638858

Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)

In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Luebeck - Department of Ophthalmology

Lübeck, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diabetic macular edema with center involvement in at least one eye
  • patients with a central retinal thickness
  • patients with a BCVA of 78-24 EDTRS letters
  • decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
  • Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening

Exclusion criteria

  • history or evidence of severe cardiac disease
  • clinical or medical history uncontrolled hypertension or diabetes
  • of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
  • ventricular tachyarrhythmias requiring ongoing treatment
  • history or evidence clinically significant peripheral vascular disease, such a intermittent claudication or prior amputation
  • clinically significant impaired renal or hepatic function

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. Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months

    Time frame: 12 months

    Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months

Secondary outcomes

  1. to document changes in best corrected visual acuity measured on 4 meters

    Time frame: 12 months

    to document changes in best corrected visual acuity measured on 4 meters

  2. to document changes in microperimetry

    Time frame: 12 months

    to document changes in microperimetry

  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 of Evaluate the Effects of 0.5mg Intraocular Ranibizumab (Lucentis)Injections on Retinal Function in Patients With Diabetic Macular Edema (DME) During Twelve Months

Important dates

Study start
2011
Primary completion
2014
First posted
Jul 12, 2012
Registry last updated
Jul 8, 2014

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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