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Ranibizumab "Treat and Extend" in Diabetic Macular Edma (OPTIMAL)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01297569
First received: February 15, 2011
Last updated: February 20, 2017
Last verified: February 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetic Macular Edema | Drug: Ranibizumab | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis ( Novartis Pharmaceuticals ):
Primary Outcome Measures:
- Change in Best Corrected Visual Acuity(BCVA) [ Time Frame: from month 0 (baseline) to month 12 ]
Secondary Outcome Measures:
- change in central retinal thickness (CRT) [ Time Frame: from month 0 to month 12 ]
- the number of injections needed [ Time Frame: 12 months ]
- the number of patients with improvement in BCVA from baseline [ Time Frame: 12 months ]
- the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84 [ Time Frame: 12 months ]
| Enrollment: | 7 |
| Study Start Date: | January 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ranibizumab | Drug: Ranibizumab |
Eligibility| Ages Eligible for Study: | 18 Years to 18 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297569
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297569
Locations
| Norway | |
| Novartis Investigative Site | |
| Oslo, Norway, 0264 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01297569 History of Changes |
| Other Study ID Numbers: |
CRFB002DNO02 2010-021182-76 ( EudraCT Number ) |
| Study First Received: | February 15, 2011 |
| Last Updated: | February 20, 2017 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
|
Diabetic macular edema Macular edema DME Diabetic retinopathy |
Diabetic eye disease anti-VEGF ranibizumab Lucentis |
Additional relevant MeSH terms:
|
Edema Macular Edema Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab |
Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 19, 2017