Ranibizumab and Vitrectomy in the Therapy of Diabetic Macular Edema (The RAVIT-DME-Trial)

Phase 1

• Conditions: therapy of diabetic macular edema; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-001006-24-DE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-24
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

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.

?The investigator has to be clinically convinced about vitrectomy might be beneficial and appropriate for the patient enrolled.

?Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 6 months prior to baseline

?Previous vitrectomy in the study eye

?Previous cataract surgery in the study eye within 6 months prior to baseline

?Pseudophakia with opening of the posterior capsule by surgery or YAG laser capsulotomy 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: number of injections of study drug during the first year of treatment<br><br>mean change from baseline in BCVA at month 12 <br>;Secondary Objective: •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<br>•Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following visit 3<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)<br>•AEs<br>;Primary end point(s): •Number of injections of study drug during the first year of treatment<br>•Mean change from baseline in BCVA at month 12 (visit 13)<br>;Timepoint(s) of evaluation of this end point: month 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •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<br>•Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following visit 3<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)<br>•AEs<br>;Timepoint(s) of evaluation of this end point: month 12