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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001006-24-DE

Enrollment

110

Registered

2013-06-24

Start date

2013-08-23

Completion date

Unknown

Last updated

2017-10-30

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

Conditions

therapy of diabetic macular edema

Interventions

Pharmaceutical Form: Trade Name: Lucentis Product Name: Lucentis Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 1,3) ? Central retinal thickness stated by SD-OCT 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

Design outcomes

Primary

Measure	Time frame
Main Objective: number of injections of study drug during the first year of treatment mean change from baseline in BCVA at month 12 ;Secondary Objective: • Proportion of patients with a vision acuity loss of fewer than 15 letters at month 12 (visit 13) compared with baseline • Proportion of patients with a vision acuity loss of more than 15 letters at month 12 (visit 13) compared with baseline • Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following visit 3 • Drop out rates • Rate of non-responders • Retinal lesions • Changes in retinal thickness from baseline at month 4 and 12 (visit 13) • AEs ;Primary end point(s): • Number of injections of study drug during the first year of treatment • Mean change from baseline in BCVA at month 12 (visit 13) ;Timepoint(s) of evaluation of this end point: month 12	—

Measure

Time frame

Main Objective: number of injections of study drug during the first year of treatment mean change from baseline in BCVA at month 12 ;Secondary Objective: • Proportion of patients with a vision acuity loss of fewer than 15 letters at month 12 (visit 13) compared with baseline • Proportion of patients with a vision acuity loss of more than 15 letters at month 12 (visit 13) compared with baseline • Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following visit 3 • Drop out rates • Rate of non-responders • Retinal lesions • Changes in retinal thickness from baseline at month 4 and 12 (visit 13) • AEs ;Primary end point(s): • Number of injections of study drug during the first year of treatment • Mean change from baseline in BCVA at month 12 (visit 13) ;Timepoint(s) of evaluation of this end point: month 12

—

Secondary

Measure	Time frame
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 • Proportion of patients with a vision acuity loss of more than 15 letters at month 12 (visit 13) compared with baseline • Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following visit 3 • Drop out rates • Rate of non-responders • Retinal lesions • Changes in retinal thickness from baseline at month 4 and 12 (visit 13) • AEs ;Timepoint(s) of evaluation of this end point: month 12	—

Measure

Time frame

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 • Proportion of patients with a vision acuity loss of more than 15 letters at month 12 (visit 13) compared with baseline • Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following visit 3 • Drop out rates • Rate of non-responders • Retinal lesions • Changes in retinal thickness from baseline at month 4 and 12 (visit 13) • AEs ;Timepoint(s) of evaluation of this end point: month 12

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026