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Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion

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ClinicalTrials.gov Identifier: NCT01085734
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Retinal Vein Occlusions
Interventions: Drug: Avastin
Drug: Osurdex

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at a single center. The first subject for this study was screened on 18MAR2010 and enrolled on 26MAR2010. The subjects were existing patients in our medical clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total there were 10 screen failures; 4 did not meet the visual acuity requirements,3 did not meet the OCT requirements. One subject withdrew consent prior to randomization and one withdrew prior to randomization due to health issues

Reporting Groups
  Description
Group 1 Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 micros
Group 2 Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.

Participant Flow:   Overall Study
    Group 1   Group 2
STARTED   15   15 
COMPLETED   14   11 
NOT COMPLETED   1   4 
Adverse Event                0                2 
Death                1                0 
Lost to Follow-up                0                1 
Withdrawal by Subject                0                1 



  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
  Description
Group 1 Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
Group 2 Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 15   15   30 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   6   4   10 
>=65 years   9   11   20 
Age 
[Units: Years]
Mean (Standard Deviation) 		 67  (13)   69  (19)   68  (16) 
Gender 
[Units: Participants]
 		     
Female   5   7   12 
Male   10   8   18 


  Outcome Measures

1.  Primary:   Change From Baseline Visual Acuity at 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Number of Injections Needed   [ Time Frame: baseline to 6 months ]
  Show Outcome Measure 2

3.  Secondary:   Change in Macular Thickness and Macular Volume   [ Time Frame: 6 months ]
  Show Outcome Measure 3


  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
No text entered.


  More Information

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: Raj K. Maturi, MD
Organization: Raj K. Maturi, MD, PC
phone: 317-817-1414
e-mail: rmaturi@gmail.com



Responsible Party: Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.
ClinicalTrials.gov Identifier: NCT01085734     History of Changes
Other Study ID Numbers: OA001
First Submitted: March 10, 2010
First Posted: March 12, 2010
Results First Submitted: April 24, 2013
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014