Ranibizumab "Treat and Extend" in Diabetic Macular Edma (OPTIMAL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01297569 |
Recruitment Status
:
Completed
First Posted
: February 16, 2011
Last Update Posted
: February 23, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema | Drug: Ranibizumab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
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 |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Ranibizumab | Drug: Ranibizumab |
- Change in Best Corrected Visual Acuity(BCVA) [ Time Frame: from month 0 (baseline) to month 12 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 18 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297569
Norway | |
Novartis Investigative Site | |
Oslo, Norway, 0264 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Additional Information:
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01297569 History of Changes |
Other Study ID Numbers: |
CRFB002DNO02 2010-021182-76 ( EudraCT Number ) |
First Posted: | February 16, 2011 Key Record Dates |
Last Update Posted: | February 23, 2017 |
Last Verified: | February 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 |