Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)
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
2 other identifiers
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 2, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedJuly 8, 2014
July 1, 2014
2.8 years
July 2, 2012
July 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
12 months
Secondary Outcomes (3)
to document changes in best corrected visual acuity measured on 4 meters
12 months
to document changes in microperimetry
12 months
to document changes in optical coherence tomography (OCT)
12 months
Study Arms (1)
Lucentis (Ranibizumab)
EXPERIMENTALInterventions
Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Luebeck - Department of Ophthalmology
Lübeck, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salvatore Grisanti, M.D. Prof.
University of Luebeck - Department of Ophthalmology: Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 2, 2012
First Posted
July 12, 2012
Study Start
October 1, 2011
Primary Completion
July 1, 2014
Last Updated
July 8, 2014
Record last verified: 2014-07