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:
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

July 27, 2010
January 18, 2013
September 2010
April 2013   (final data collection date for primary outcome measure)
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 ]
Mean change from baseline in Best Corrected Visual Acuity (BCVA) over a 12 month treatment period. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01171976 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Evaluate whether the mean 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 ]
  • Demonstrate a stabilizing effect of adjunctive laser, comparing 0.5mg ranibizumab TE with adjunctive laser with 0.5mg ranibizumab TE. [ Time Frame: 12 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 compared to 0.5 mg ranibizumab PRN. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare the changes in central retinal thickness and central subfield thickness 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 ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Diabetic Macular Edema
Drug: Ranibizumab
  • Experimental: Ranibizumab 0.5 mg "Treat and Extend" and Laser
    Intervention: Drug: Ranibizumab
  • Experimental: Ranibizumab 0.5 mg "Treat and Extend" alone
    Intervention: Drug: Ranibizumab
  • Active Comparator: Ranibizumab 0.5 mg alone, given PRN
    Intervention: Drug: Ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
374
April 2013
April 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   France,   Greece,   Hungary,   Ireland,   Italy,   Netherlands,   Poland,   Portugal,   Spain,   Switzerland,   United Kingdom
 
NCT01171976
CRFB002D2304, 2010-019795-74
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP