Trial record 3 of 1323 for:
retain
Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus (RETAIN)
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01171976
First received: July 27, 2010
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Macular Edema |
Drug: Ranibizumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
Drug Information available for:
Ranibizumab
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Mean average change from baseline in Best Corrected Visual Acuity (BCVA) over a 12 month treatment period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate whether the mean average change from baseline in BCVA obtained with either a 0.5 mg ranibizumab TE with adjunctive laser, or with 0.5 mg ranibizumab TE is non-inferior to 0.5 mg ranibizumab PRN [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Investigate within the TE dosing concepts the impact of laser treatment on the number of retreatments. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
- Investigate the efficacy of 0.5 mg ranibizumab TE with adjunctive laser, 0.5 mg ranibizumab TE and 0.5 mg ranibizumab PRN measured by the overall score assessed by VFQ-25 and EQ-5D. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Time course of mean BCVA change from baseline to Month 12, and up to Month 24 obtained with either a 0.5 mg ranibizumab TE with adjunctive laser, or with 0.5 mg ranibizumab TE and with 0.5 mg ranibizumab PRN. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- To compare the changes in development of central subfield thickness (CSFT) of 0.5 mg ranibizumab TE with adjunctive laser, 0.5 mg ranibizumab TE and 0.5 mg ranibizumab PRN over time. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 374 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ranibizumab 0.5 mg "Treat and Extend" and Laser | Drug: Ranibizumab |
| Experimental: Ranibizumab 0.5 mg "Treat and Extend" alone | Drug: Ranibizumab |
| Active Comparator: Ranibizumab 0.5 mg alone, given PRN | Drug: Ranibizumab |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patient
- Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization [WHO] guidelines) with glycosylated hemoglobin (HbA1c) ≤ 12.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes. Treatment for diabetes must have been stable for at least 3 month.
Ocular
- Patients with visual impairment due to DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye.
- BCVA ≥ 39 and ≤78 letters in the study eye and, inclusively, using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) at screening.
- Concomitant conditions in the study eye are only permitted if, in the opinion of the investigator, they do not prevent improvement of visual acuity on study treatment.
Exclusion Criteria:
Patient Compliance/ Administrative
- Pregnant or nursing (lactating) women.
Ocular medical history
- Active intraocular inflammation (grade trace or above) in either eye at enrollment.
- Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at the time of enrollment.
- History of uveitis in either eye at any time.
- Structural damage within 0.5 disc diameter of the center of the macular in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
- Uncontrolled glaucoma in either eye at screening.
Prior Ocular treatments
- Panretinal laser photocoagulation in the study eye within 6 months prior to randomization.
- Focal/grid laser photocoagulation in the study eye within 3 months prior to randomization.
- Treatment with anti-angiogenic drugs in either eye.
Systemic conditions or treatments
- History of stroke within 6 months prior to enrollment.
- Renal failure requiring dialysis.
- Untreated diabetes mellitus.
- Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171976
Show 68 Study Locations
Show 68 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01171976 History of Changes |
| Other Study ID Numbers: | CRFB002D2304, 2010-019795-74 |
| Study First Received: | July 27, 2010 |
| Last Updated: | January 18, 2013 |
| Health Authority: | United States: Food and Drug Administration Belgium: Agence Fédérale des Médicaments et des Produits de Santé Département R&D Czech Republic: State Institute for Drug Control France: Agence Française de Sécurité Sanitaire des Produits de Santé Greece: Ministry of Health & Social Solidarity, (National Organization for Medicines (EOF)) Hungary: National Institute of Pharmacy Italy: Agenzia Italiana del Farmaco Ireland: Clinical Trials,Reciept and Validation unit, Irish Medicines Board (IMB) Netherlands:Centrale Commissie Mensgebonden Onderzoek Poland: Urzad Rejestracji Produktow Leczniczych Portugal:Instituto Nacional da Farmácia e do Medicamento Spain: Agencia Española de Medicamentos y Productos Sanitarios Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
DME Diabetic macula edema RETAIN ranibizumab |
Additional relevant MeSH terms:
|
Diabetes Mellitus Edema Macular Edema Vision, Low Vision Disorders Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013