Clinical trial NCT02665689: Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab
Official title: Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Visual Acuity Reduced Transiently
Macular Edema, Cystoid
Keywords: Diabetic Macular Edema, Ranibizumab, Visual Acuity, Diabetic Control
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2016-01-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the prospective randomized study is to investigate whether a intensified diabetic control program leads to better final visual acuity and less frequent diabetic ocular complications in patients with diabetic retinopathy when compared with a normal diabetic treatment.

Detailed description: Patients with diabetic macular edema (DME) will be treated with intravitreal ranibizumab injections and the effect of optimal control of internal factors (eg. glycemia, blood pressure etc) on final functional (best corrected visual acuity-CBVA) and morphological (central retinal thickness-CRT) will be investigated. Patients will be randomized into two groups: Group with intensified diabetic control will be follow and investigated monthly at department of diabetology, endocrinology and nutritional medicine (Campus Benjamin Franklin) in Berlin with aim to reach the optimal glycemic control defined as HbA1c \< 6,5%. Further, triglycerides values \< 140 mg/dl and blood pressure \< 140/90 mmHg will be pursued. Second group of patients will be followed by their general practitioner and in the study center only blood samples will be taken quarterly without active medical intervention.

BCVA, CRT and the number of required ranibizumab injections will we evaluated and compared between both study groups.

Eligibility criteria: Inclusion Criteria:

- Patients with diabetic macular edema relevant to visual acuity

* OCT central retinal thickness ≥ 250µm
* HbA1c \> 6,5% at initial visit
* BCVA ≤0.8 and ≥0.05
* Age ≥18 years
* Written patient informed consent given

Exclusion Criteria:

* Previous treatment with intravitreal drugs in last 6 months
* Vitreous hemorrhage as a consequence of proliferative retinopathy
* Pregnancy
* Blood pressure of ≥ 180/100 (or uncontrolled pressures under pharmacological therapy)
* Chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel disease, Addison´s disease, Cushing Syndrome, Uveitis)
* Systemic cortisone or anti-VEGF therapy
* Acute systemic or ocular infectious diseases

Primary outcomes:
measure: Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 12 Baseline Visit
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Number of Treatments With Ranibizumab up to 6, 12, 18 and 24 Months of Treatment
timeFrame: Baseline to 12 months
measure: Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 6, 12, 24 and Baseline Visit
timeFrame: Baseline to 12 months
measure: Macular Thickness Change at 6, 12, 18 and 24 Months Compared to Baseline
timeFrame: Baseline to 12 months
measure: Time to Reach Target HbA1c
timeFrame: 24 months
measure: Number of Panretinal Laser Photocoagulation (PRP) Treatments Necessary for Neovascular Complications
timeFrame: Baseline to 12 months
measure: Number of Participants With Retinal Detachment, Central Retinal Artery Occlusion, or Endophthalmitis and/or Ocular Adverse Events That Are Related to Treatment
timeFrame: Baseline to 12 months
measure: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Ophthalmology, Charite, Berlin
Study officials:
References: