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Ranibizumab "Treat and Extend" in Diabetic Macular Edma (OPTIMAL)

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 4

Locations

Norway

Study Type

Interventional

Intervention

Ranibizumab

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic macular edema, Macular edema, DME, Diabetic retinopathy, Diabetic eye disease, anti-VEGF, ranibizumab, Lucentis

Eligibility Criteria

18 Years - 18 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranibizumab

Arm Description

Outcomes

Primary Outcome Measures

Change in Best Corrected Visual Acuity(BCVA)

Secondary Outcome Measures

change in central retinal thickness (CRT)

the number of injections needed

the number of patients with improvement in BCVA from baseline

the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84

Full Information

NCT ID

NCT01297569

First Posted

February 15, 2011

Last Updated

February 20, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01297569

Brief Title

Ranibizumab "Treat and Extend" in Diabetic Macular Edma

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

Keywords

Diabetic macular edema, Macular edema, DME, Diabetic retinopathy, Diabetic eye disease, anti-VEGF, ranibizumab, Lucentis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Primary Outcome Measure Information:

Title

Change in Best Corrected Visual Acuity(BCVA)

Time Frame

from month 0 (baseline) to month 12

Secondary Outcome Measure Information:

Title

change in central retinal thickness (CRT)

Time Frame

from month 0 to month 12

Title

the number of injections needed

Time Frame

12 months

Title

the number of patients with improvement in BCVA from baseline

Time Frame

12 months

Title

the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0264

Country

Norway

12. IPD Sharing Statement

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Ranibizumab "Treat and Extend" in Diabetic Macular Edma

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