Safety and Efficacy of Ranibizumab in Diabetic Macular Edema

Visual Impairment Due to Diabetic Macular Edema Clinical Trial

— RELATION  

Official title:

A 12-month, Two-armed, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Laser Photocoagulation as Adjunctive to Ranibizumab Intravitreal Injections vs. Laser Photocoagulation Monotherapy in Patients With Visual Impairment Due to Diabetic Macular Edema Followed by a 12 Month Follow up Period

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01131585
• Other study ID #: CRFB002DDE13
• Secondary ID: 2010-018852-29
• Status: Terminated
• Phase: Phase 3
• First received: May 25, 2010
• Last updated: August 20, 2012
• Start date: June 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 128
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Visual acuity impairment caused by macular edema in at least one eye

• Type 1 or type 2 diabetes mellitus

• Stable medication of diabetes in past 3 month

Exclusion Criteria:

• Patients with uncontrolled systemic or ocular diseases

• Laser photocoagulation in the study eye for the last 3 months

• Any history of any intraocular surgery in the study eye within the past 3 months

• Blood pressure > 160/100 mmHg

Other protocol defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Visual Impairment Due to Diabetic Macular Edema

Intervention

Procedure:
• Active laser photocoagulation
Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Drug:
• Sham injections
Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
• Ranibizumab 0.5 mg
Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aschaffenburg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Darmstadt
Germany	Novartis Investigative Site	Dessau
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Eichstaett
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Giessen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Landshut
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Mühlheim
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Münster
Germany	Novartis Investigative Site	Nuernberg
Germany	Novartis Investigative Site	Postdam
Germany	Novartis Investigative Site	Recklinghausen
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Rosenheim
Germany	Novartis Investigative Site	Siegburg
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12	Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.	12 months	No

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