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Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study (READ 3)

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ClinicalTrials.gov Identifier: NCT01077401
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Diabetic Macular Edema
Interventions Drug: Ranibizumab
Drug: ranibizumab
Enrollment 152
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ranibizumab 0.5mg Ranibizumab 2.0 mg
Hide Arm/Group Description

Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

Period Title: Overall Study
Started 77 75
Completed 59 54
Not Completed 18 21
Arm/Group Title Ranibizumab 0.5mg Ranibizumab 2.0 mg Total
Hide Arm/Group Description

Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

Total of all reporting groups
Overall Number of Baseline Participants 77 75 152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 77 participants 75 participants 152 participants
64.8
(35 to 87)
63.5
(48 to 84)
64.1
(35 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 75 participants 152 participants
Female
30
  39.0%
37
  49.3%
67
  44.1%
Male
47
  61.0%
38
  50.7%
85
  55.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 75 participants 152 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   5.2%
5
   6.7%
9
   5.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   7.8%
13
  17.3%
19
  12.5%
White
45
  58.4%
39
  52.0%
84
  55.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
22
  28.6%
18
  24.0%
40
  26.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 77 participants 75 participants 152 participants
77 75 152
1.Primary Outcome
Title Deaths Due to Myocardial Infarction
Hide Description [Not Specified]
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ranibizumab 0.5mg Ranibizumab 2.0 mg
Hide Arm/Group Description:

Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

Overall Number of Participants Analyzed 77 75
Measure Type: Number
Unit of Measure: participants
1 3
2.Secondary Outcome
Title Mean Change in Best Corrected Visual Acuity From Baseline to Month 6
Hide Description Mean change in best corrected visual acuity (BCVA) (ETDRS) at 4 meters in the study eye over time through month 6.
Time Frame baseline 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ranibizumab 0.5mg Ranibizumab 2.0 mg
Hide Arm/Group Description:

Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

Overall Number of Participants Analyzed 77 75
Mean (Standard Deviation)
Unit of Measure: letters
9.34  (10.34) 7.04  (8.33)
3.Secondary Outcome
Title Mean Change in Retinal Thickness at Month 6
Hide Description [Not Specified]
Time Frame baseline to6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for 4 participants in the Ranibizumab 0.5mg group for this outcome measure.
Arm/Group Title Ranibizumab 0.5mg Ranibizumab 2.0 mg
Hide Arm/Group Description:

Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

Overall Number of Participants Analyzed 73 75
Mean (Standard Deviation)
Unit of Measure: µm
168.57  (145.67) 159.69  (124.50)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ranibizumab 0.5mg Ranibizumab 2.0 mg
Hide Arm/Group Description

Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.

Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.

All-Cause Mortality
Ranibizumab 0.5mg Ranibizumab 2.0 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ranibizumab 0.5mg Ranibizumab 2.0 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/77 (1.30%)      3/75 (4.00%)    
Cardiac disorders     
Deaths from Myocardial Infarction within 6 months of starting study * 1  1/77 (1.30%)  1 3/75 (4.00%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Adverse Events
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ranibizumab 0.5mg Ranibizumab 2.0 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/77 (1.30%)      0/75 (0.00%)    
Eye disorders     
Loss of 30 or more letters * 1  1/77 (1.30%)  1 0/75 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Adverse Events
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
Layout table for Results Point of Contact information
Name/Title: Quan Dong Nguyen, MD, MSc
Organization: University of Nebraska
Phone: 4025591855
EMail: quan.nguyen@unmc.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01077401    
Other Study ID Numbers: NA_00034586
First Submitted: February 26, 2010
First Posted: March 1, 2010
Results First Submitted: August 30, 2016
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017