The Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study

This study has been completed.

Sponsor:

Collaborators:

Juvenile Diabetes Research Foundation

Genentech, Inc.

Information provided by (Responsible Party):

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00407381

First received: December 1, 2006

Last updated: March 20, 2017

Last verified: March 2017

History of Changes

Results First Received: August 30, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: No masking; Primary Purpose: Treatment
Condition:	Diabetic Macular Edema
Interventions:	Drug: Ranibizumab Procedure: Laser photocoagulation

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Ranibizumab Only	Ranibizumab (RBZ) intravitreal injection alone Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria.
Laser Only	Laser photocoagulation Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.
Laser With Ranibizumab (RBZ)	Laser following intravitreal injection of RBZ Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria. Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.

Description

Ranibizumab Only

Ranibizumab (RBZ) intravitreal injection alone

Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria.

Laser Only

Laser photocoagulation

Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.

Laser With Ranibizumab (RBZ)

Laser following intravitreal injection of RBZ

Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.

Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.

Participant Flow: Overall Study

	Ranibizumab Only	Laser Only	Laser With Ranibizumab (RBZ)
STARTED	42	42	42
COMPLETED	39	38	40
NOT COMPLETED	3	4	2

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
Ranibizumab Only	RBZ intravitreal injection alone Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria.
Laser Only	Laser photocoagulation Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.
Laser With RBZ	Laser following intravitreal injection of RBZ Ranibizumab: Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and PRN with dosing criteria. Laser photocoagulation: Laser photocoagulation in either focal or grid pattern as determined by investigator.
Total	Total of all reporting groups

Baseline Measures

	Ranibizumab Only	Laser Only	Laser With RBZ	Total
Overall Participants Analyzed [Units: Participants]	42	42	42	126

Age [Units: Years] Mean (Full Range)	62 (32 to 84)	62 (34 to 86)	62 (35 to 82)	62 (32 to 86)

Sex: Female, Male [Units: Participants] Count of Participants
Female	29 69.0%	23 54.8%	22 52.4%	74 58.7%
Male	13 31.0%	19 45.2%	20 47.6%	52 41.3%

Outcome Measures

1. Primary:

Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6 [ 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
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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 NOT 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.

Results Point of Contact:

Name/Title: Quan Dong Nguyen, MD, MSc
Organization: University of Nebraska
phone: 4025591855
e-mail: quan.nguyen@unmc.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Do DV, Nguyen QD, Khwaja AA, Channa R, Sepah YJ, Sophie R, Hafiz G, Campochiaro PA; READ-2 Study Group. Ranibizumab for edema of the macula in diabetes study: 3-year outcomes and the need for prolonged frequent treatment. JAMA Ophthalmol. 2013 Feb;131(2):139-45.

Responsible Party:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00407381 History of Changes
Other Study ID Numbers:	NA_00005254
Study First Received:	December 1, 2006
Results First Received:	August 30, 2016
Last Updated:	March 20, 2017

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