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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003943-32-DE

Enrollment

120

Registered

2015-03-31

Start date

2015-08-06

Completion date

Unknown

Last updated

2021-09-13

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

Conditions

Diabetic macular edema MedDRA version: 17.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853

Interventions

Trade Name: Lucentis Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with diabetic macular edema relevant to visual acuity -OCT retinal thickness >= 250µm -HbA1c > 6,5% at initial visit -BCVA = 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the influence of an intensified diabetes control program on treatment of diabetic macular edema.;Primary end point(s): Change of best corrected visual acuity (BCVA) in ETDRS letters score at month 12 when compared with baseline.;Secondary Objective: To evaluate: -the number of treatments with ranibizumab -the mean average change in BCVA -the macular thickness (as measured with OCT) -the time needed to reach the target HbA1c -the number of neovascular complications with need of PRP -the safety of the treatment of DME with ranibizumab based on ocular and systemic adverse events;Timepoint(s) of evaluation of this end point: Month 12	—

Measure

Time frame

Main Objective: To evaluate the influence of an intensified diabetes control program on treatment of diabetic macular edema.;Primary end point(s): Change of best corrected visual acuity (BCVA) in ETDRS letters score at month 12 when compared with baseline.;Secondary Objective: To evaluate: -the number of treatments with ranibizumab -the mean average change in BCVA -the macular thickness (as measured with OCT) -the time needed to reach the target HbA1c -the number of neovascular complications with need of PRP -the safety of the treatment of DME with ranibizumab based on ocular and systemic adverse events;Timepoint(s) of evaluation of this end point: Month 12

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Secondary

Measure	Time frame
Secondary end point(s): -Number of treatments with ranibizumab up to 6, 18 and 24 months of treatment respectively -Mean average change in BCVA at 6 , 12 , 18 and 24 months after initial treatment -Macular thickness (as measured with OCT) at 6 , 12 , 18 and 24 months after initial treatment -Time to reach target HbA1c -Number of neovascular complications: need for PRP -Rates of ocular and systemic adverse events (retinal detachment, central retinal artery occlusion, endophthalmitis; rates of stroke, myocardial infarction, severe hypoglycemia);Timepoint(s) of evaluation of this end point: 1.-3. months 6, 12, 18 and 24 4.-6. EoS	—

Measure

Time frame

Secondary end point(s): -Number of treatments with ranibizumab up to 6, 18 and 24 months of treatment respectively -Mean average change in BCVA at 6 , 12 , 18 and 24 months after initial treatment -Macular thickness (as measured with OCT) at 6 , 12 , 18 and 24 months after initial treatment -Time to reach target HbA1c -Number of neovascular complications: need for PRP -Rates of ocular and systemic adverse events (retinal detachment, central retinal artery occlusion, endophthalmitis; rates of stroke, myocardial infarction, severe hypoglycemia);Timepoint(s) of evaluation of this end point: 1.-3. months 6, 12, 18 and 24 4.-6. EoS

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Countries

Germany

Contacts

Public ContactPrincipal Coordinating Investigator

Charité University Medicine Berlin

antonia.joussen@charite.de00493084452331

Outcome results

None listed

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