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

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

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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.
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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
Overall Participants Analyzed; [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 ]

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2. Secondary:

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

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  Serious Adverse Events

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  Other Adverse Events

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  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

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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

Responsible Party:	Ivan J. Suner, MD, Retina Associates of Florida, P.A.
ClinicalTrials.gov 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