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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01638858

Enrollment

Registered

2012-07-12

Start date

2011-10-31

Completion date

Unknown

Last updated

2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

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.

Interventions

DRUGLucentis (Ranibizumab)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. diabetic macular edema with center involvement in at least one eye 2. patients with a central retinal thickness 3. patients with a BCVA of 78-24 EDTRS letters 4. decrease in vision is due to DME and not due to other causes, in the opinion of the investigator 5. Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening

Exclusion criteria

1. history or evidence of severe cardiac disease 2. clinical or medical history uncontrolled hypertension or diabetes 3. of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months 4. ventricular tachyarrhythmias requiring ongoing treatment 5. history or evidence clinically significant peripheral vascular disease, such a intermittent claudication or prior amputation 6. clinically significant impaired renal or hepatic function

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
to document changes in best corrected visual acuity measured on 4 meters	12 months	to document changes in best corrected visual acuity measured on 4 meters
to document changes in microperimetry	12 months	to document changes in microperimetry
to document changes in optical coherence tomography (OCT)	12 months	to document changes in optical coherence tomography (OCT)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026