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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01171976
First received: July 27, 2010
Last updated: September 10, 2014
Last verified: September 2014
Results First Received: March 31, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Intervention: Drug: Ranibizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 373 patients with macular edema and visual impairment secondary to DME were enrolled. A total of 372 patients were randomized. One patient was excluded from all analyses due to administrative problems

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Antimicrobial eye drops were dispensed at each study visit (PRN ranibizumab) or at visits with scheduled injections (TE ranibizumab + laser or TE ranibizumab alone).

Reporting Groups
  Description
TE Ranibizumad 0.5 mg and Laser Patients received an injection ranibizumab and laser therapy.
TE Ranibizumab 0.5 mg Alone Patients received an intravitreal injection ranibizumab
PRN Ranibizumab 0.5 mg Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.

Participant Flow:   Overall Study
    TE Ranibizumad 0.5 mg and Laser     TE Ranibizumab 0.5 mg Alone     PRN Ranibizumab 0.5 mg  
STARTED     121     128     123  
Safety Set     126 [1]   126 [2]   118 [3]
COMPLETED     107     117     108  
NOT COMPLETED     14     11     15  
Protocol Violation                 0                 0                 1  
Death                 2                 4                 1  
Lost to Follow-up                 4                 0                 2  
Withdrawal by Subject                 1                 5                 6  
Abnormal test result                 1                 0                 0  
Adverse Event                 6                 2                 5  
[1] Include 4 from PRN and 3 from TE alone who got laser treatment, exclude 2 with no laser treatment.
[2] Exclude 1 who did not get drug and 3 got laser treatment, include 2 from 1st arm with no laser
[3] Exclude 1 who did not get drug and 4 got laser treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Randomized Set comprised all randomized patients, ie those given a randomization number.

Reporting Groups
  Description
TE Ranibizumad 0.5 mg and Laser Patients received an injection ranibizumab and laser therapy.
TE Ranibizumab 0.5 mg Alone Patients received an intravitreal injection ranibizumab
PRN Ranibizumab 0.5 mg Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Total Total of all reporting groups

Baseline Measures
    TE Ranibizumad 0.5 mg and Laser     TE Ranibizumab 0.5 mg Alone     PRN Ranibizumab 0.5 mg     Total  
Number of Participants  
[units: participants]
  121     128     123     372  
Age  
[units: Years]
Mean ± Standard Deviation
  63.7  ± 9.07     63.0  ± 9.83     64.5  ± 9.66     63.7  ± 9.53  
Gender  
[units: Participants]
       
Female     43     51     46     140  
Male     78     77     77     232  



  Outcome Measures
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1.  Primary:   Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12   [ Time Frame: Baseline to Month 12 ]

2.  Secondary:   Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24   [ Time Frame: Baseline to Month 24 ]

3.  Secondary:   Visual Acuity of the Study Eye: Change From Baseline at Month 12   [ Time Frame: Baseline and Month 12 ]

4.  Secondary:   Visual Acuity of the Study Eye: Change From Baseline at Month 24   [ Time Frame: Baseline and Month 24 ]

5.  Secondary:   Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12   [ Time Frame: Baseline, Month 12 ]

6.  Secondary:   Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24   [ Time Frame: Baseline, 24 month ]

7.  Secondary:   Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12   [ Time Frame: Baseline, Month 12 ]

8.  Secondary:   Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24   [ Time Frame: Baseline and 24 month ]

9.  Secondary:   Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24   [ Time Frame: Baseline, Month 12 and Month 24 ]

10.  Secondary:   EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24   [ Time Frame: Baseline, Month 12 and Month 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


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
Results First Received: March 31, 2014
Last Updated: September 10, 2014
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