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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: July 27, 2010
Last updated: January 18, 2013
Last verified: January 2013
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.
Diabetic Macular Edema
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
||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
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 ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
Experimental: Ranibizumab 0.5 mg "Treat and Extend" and Laser
Experimental: Ranibizumab 0.5 mg "Treat and Extend" alone
Active Comparator: Ranibizumab 0.5 mg alone, given PRN
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171976
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 27, 2010
||January 18, 2013
||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
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by Novartis:
Diabetic macula edema
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Glucose Metabolism Disorders
Endocrine System Diseases
Signs and Symptoms
Nervous System Diseases