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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Raj K. Maturi, MD, Maturi, Raj K., M.D., P.C.

ClinicalTrials.gov Identifier:

NCT01085734

First received: March 10, 2010

Last updated: March 13, 2014

Last verified: March 2014

History of Changes

Results First Received: April 24, 2013

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

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
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

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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
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
Number of Participants [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

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1. Primary:

Change From Baseline Visual Acuity at 6 Months [ Time Frame: 6 months ]

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2. Secondary:

Number of Injections Needed [ Time Frame: baseline to 6 months ]

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3. Secondary:

Change in Macular Thickness and Macular Volume [ 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: 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
Study First Received:	March 10, 2010
Results First Received:	April 24, 2013
Last Updated:	March 13, 2014
Health Authority:	United States: Institutional Review Board

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