Ranibizumab and Vitrectomy in the Therapy of Diabetic Macular Edema

Recruitment & Eligibility

Status: Recruiting stopped after recruiting started

Sex: All

Target Recruitment: 15

Inclusion Criteria

Patients aged 18 years and older
- - - Diabetes mellitus type 2 (insulin-dependent diabetes mellitus (IDDM) and noninsulin-dependent diabetes mellitus (NIDDM))
- - - Clinical significant diabetic macular edema (diffuse or focal)
- - - Visual acuity (decimal) reduced by diabetic macular edema to = 0,3 and = 0,05 (LogMar = 1,3 and = 0,5) stated by EDTRS charts.
- - - Signed informed consent

Exclusion Criteria

The investigator is clinically not convinced about vitrectomy being indicated or the possible side effects outweigh the possible positive effects of vitrectomy
- - - Diabetes mellitus type 1
- - - Visual acuity of the study eye (decimal) > 0,3 (LogMar < 0,5)
- - - Visual acuity of the study eye (decimal) < 0,05 (LogMar > 1,3)
- - - Central retinal thickness stated by SD-OCT < 250 µm
- - - Any clouding of optical media influencing the evaluation of the retina
- - - Previous focal laser coagulation of the macula in the study eye within 3 months prior to baseline
- - - Previous treatment of diabetic macular edema involving intravitreal steroids or VEGF blockers within 3 months prior to baseline
- - - Previous vitrectomy in the study eye
- - - Previous cataract surgery in the study eye within 3 months prior to baseline
- - - Pseudophakia with opening of the posterior capsule by surgery or YAG laser capsulotomy within 3 months prior to baseline
- - - History of glaucoma (including or excluding local or systemic therapy) in either eye
- - - Uveitis or extraocular inflammation in either eye
- - - Pseudoexfoliative syndrome
- - - Known ocular ischemia syndrome in either eye (occlusion of extraocular arteries, influencing the vascularisation of the study eye)
- - - Retinal venous occlusion in the study eye
- - - History of retinal detachment (including or excluding any therapy) in either eye
- - - Tractive retinal detachment due to diabetic epiretinal proliferation in the study eye
- - - Intravitreal hemorrhage interfering with the assessment of the posterior pole in the study eye prior to baseline
- - - Active malignancies (history of successful treated malignancies is not an exclusion criterion)
- - - History of cerebral vascular accident or myocardial infarction within 12 months prior to baseline
- - - Diabetes mellitus with HbA1c > 10 % or if it can be expected that the patient’s diabetes cannot be controlled adequately during the trial
- - - Uncontrolled arterial Hypertension defined as a systolic value of > 180 mmHg and/or a diastolic value of > 110 mmHg
- - - Systemic therapy with steroids or anticoagulative therapy with coumarin derivatives or heparin (Aspirin or Clopidogrel is allowed)
- - - History of allergy to fluorescein or ranibizumab
- - - Women who are pregnant or planning a pregnancy
- - - Women who are breast feeding
- - - Inability to comply with study or follow-up procedures

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of injections of study drug during the first year of treatment<br><br>Mean change from baseline in BCVA at month 12 (visit 13)<br>Visual acuity measured by ETDRS-charts

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with a vision acuity loss of fewer than 15 letters at month 12 (visit 13) compared with baseline<br>- - - Proportion of patients with a vision acuity loss of more than 15 letters at month 12 (visit 13) compared with baseline (visual acuity measured by ETDRS-charts)<br>- - - Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following visit 3 (at month 2)<br>- - - Drop out rates<br>- - - Rate of non-responders<br>- - - Retinal lesions <br>- - - Changes in retinal thickness from baseline at month 4 and 12 (visit 13) via Optical Coherence Tomography (OCT)<br>- - - AEs<br>- - - Quality of Life at visit 1 (before treatment) and visit 13 (month 12); questionnaire VFQ25.<br><br>

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