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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-23

Study Completion Date

2017-06-08

Brief Summary

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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).

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Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Discretion of the investigator (DI)

ranibizumab 0.5 mg, after initial monthly treatment until maximum BCVA and no signs or no further change of disease activity, the investigator treated patients at their own discretion. There were no strict recommendations for retreatment or scheduling of upcoming visits.

Group Type EXPERIMENTAL

ranibizumab 0.5 mg

Intervention Type DRUG

intravitreal injection

Pro re nata (PRN)

ranibizumab 0.5 mg, after initial monthly therapy until maximum BCVA and no signs or no further improvement of disease activity, patients were monitored every month and retreated if any signs of disease activity occurred

Group Type ACTIVE_COMPARATOR

ranibizumab 0.5 mg

Intervention Type DRUG

intravitreal injection

Interventions

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ranibizumab 0.5 mg

intravitreal injection

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No