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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00815360
Recruitment Status : Completed
First Posted : December 30, 2008
Results First Posted : March 5, 2015
Last Update Posted : March 5, 2015
Information provided by (Responsible Party):
Ivan J. Suner, MD, Retina Associates of Florida, P.A.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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

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
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 11   11   22 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   10   11   21 
>=65 years   1   0   1 
[Units: Years]
Mean (Standard Deviation)
 57.7  (7.5)   58.3  (6.5)   58.0  (7.4) 
[Units: Participants]
Female   5   5   10 
Male   6   6   12 
Region of Enrollment 
[Units: Participants]
United States   11   11   22 

  Outcome Measures

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

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

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

Responsible Party: Ivan J. Suner, MD, Retina Associates of Florida, P.A. Identifier: NCT00815360     History of Changes
Other Study ID Numbers: Pro00002813
First Submitted: December 26, 2008
First Posted: December 30, 2008
Results First Submitted: May 23, 2013
Results First Posted: March 5, 2015
Last Update Posted: March 5, 2015