Ranibizumab "Treat and Extend" in Diabetic Macular Edma

Diabetic Macular Edema Clinical Trial

— OPTIMAL  

Official title:

An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized "Treat and Extend" Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297569
• Other study ID #: CRFB002DNO02
• Secondary ID: 2010-021182-76
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2011
• Last updated: February 20, 2017
• Start date: January 2011
• Est. completion date: November 2012

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 18 Years

Eligibility

Inclusion Criteria:

• Visual impairment due to focal or diffuse macular edema with center involvement

• Diabetes type 1 or 2, HbA1c < 12.0%

• CRT = or > 250 µm

Exclusion Criteria:

• Active inflammation or infection

• Uncontrolled glaucoma

• Iris neovascularization, active proliferative retinopathy or vitreomacular traction

• Prior laser photocoagulation according to defined timelines

• History of stroke, uncontrolled hypertension

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Ranibizumab

Locations

Country	Name	City	State
Norway	Novartis Investigative Site	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Best Corrected Visual Acuity(BCVA)		from month 0 (baseline) to month 12
Secondary	change in central retinal thickness (CRT)		from month 0 to month 12
Secondary	the number of injections needed		12 months
Secondary	the number of patients with improvement in BCVA from baseline		12 months
Secondary	the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84		12 months

External Links

•   Results for CRFB002DNO02 from Novartis Clinical Trials website