CompletedPhase 4

Study of Efficacy of Ranibizumab in Different Regimens in Patients With Diabetic Macula Edema

Germany135 participantsStarted 2015-02-23

Plain-language summary

The purpose of this study was to demonstrate that the change of best corrected visual acuity (BCVA) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 12.0% * Patients with visual impairment due to DME in at least one eye * BCVA ≥ 24 and ≤ 78 letters in the study eye Exclusion Criteria: * Active intraocular inflammation * Any active infection in either eye at the * Structural damage within 0.5 disc diameter of the center of the macula in the study eye * Uncontrolled glaucoma in either eye at screening Other protocol-defined inclusion/exclusion criteria may apply.

What they're measuring

Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)

Timeframe: Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Trial details

NCT IDNCT02366468

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-08

Results submitted2018-06-05

View on ClinicalTrials.gov More Diabetic Retinopathy trials