Influence of diabetes control on treatment of diabetic macular edema with ranibizumab

Phase 1

• Conditions: Diabetic macular edema; MedDRA version: 17.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-003943-32-DE
• Lead Sponsor: Charité University Medicine Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-31
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

-Patients with diabetic macular edema relevant to visual acuity
-OCT retinal thickness >= 250µm
-HbA1c > 6,5% at initial visit
-BCVA <= 0.8 and >= 0,05
-Age >= 18 years
-Written informed consent given
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-Previous treatment with intravitreal drugs in last 6 months
-Vitreous hemorrhage as a consequence of proliferative retinopathy which would hamper adequate diagnosis and imaging
-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
-Prior laser photocoagulation treatment within 3 months (focal / grid laser or panretinal) prior to study entry
-Current treatment with pharmaceutical preparations with which interactions can be expected
-Persons who have a fluorescein allergy
-Women who are pregnant or breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified