Ranibizumab and Peripheral Scatter Laser in Patients With Diabetic Macular Edema and Peripheral Nonperfusion (RaScaL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ivan J. Suner, MD, Retina Associates of Florida, P.A.
ClinicalTrials.gov Identifier:
NCT00815360
First received: December 26, 2008
Last updated: February 4, 2015
Last verified: October 2014
Results First Received: May 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Interventions: Drug: intravitreal injection of ranibizumab
Procedure: peripheral laser
Drug: intravitreal injection of triamcinolone acetonide
Procedure: macular laser

  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
We included 30 treatment-naïve eyes of 22 patients (8 bilateral patients) aged ≥ 18 years of age, with Type 1 or 2 diabetes mellitus and visual impairment secondary to diabetic macular edema associated with peripheral nonperfusion on Ultra Widefield Fluorescein Angiography (UWFA).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Treatment naive patients

Reporting Groups
  Description
Treatment Group 1 ranibizumab and scatter laser
Comparative Group 1 Intravitreal triamcinolone with macular laser

Participant Flow:   Overall Study
    Treatment Group 1     Comparative Group 1  
STARTED     11     11  
COMPLETED     11     11  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
Treatment Group 1 ranibizumab and scatter laser
Comparative Group 1 Intravitreal triamcinolone with macular laser
Total Total of all reporting groups

Baseline Measures
    Treatment Group 1     Comparative Group 1     Total  
Number of Participants  
[units: participants]
  11     11     22  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     11     21  
>=65 years     1     0     1  
Age  
[units: years]
Mean (Standard Deviation)
  57.7  (7.5)     58.3  (6.5)     58.0  (7.4)  
Gender  
[units: participants]
     
Female     5     5     10  
Male     6     6     12  
Region of Enrollment  
[units: participants]
     
United States     11     11     22  



  Outcome Measures
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1.  Primary:   Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6.   [ Time Frame: 6 months ]

2.  Secondary:   Mean Central Foveal Thickness (CFT) on Optical Coherence Tomography (OCT) in Microns at 6 Months   [ Time Frame: 6 months ]


  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
small study size


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Ivan J. Suner
Organization: Retina Associates of Florida, P.A.
phone: 813-875-6373
e-mail: ivansuner@gmail.com


No publications provided


Responsible Party: Ivan J. Suner, MD, Retina Associates of Florida, P.A.
ClinicalTrials.gov Identifier: NCT00815360     History of Changes
Other Study ID Numbers: Pro00002813
Study First Received: December 26, 2008
Results First Received: May 23, 2013
Last Updated: February 4, 2015
Health Authority: United States: Food and Drug Administration