Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01231633
Recruitment Status : Completed
First Posted : November 1, 2010
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Vincent. A. Deramo, M.D., Long Island Vitreoretinal Consultants

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Macular Edema
Central Retinal Vein Occlusion
Interventions Drug: Ozurdex
Drug: Avastin
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ozurdex & Avastin Avastin Only
Hide Arm/Group Description

Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.

Ozurdex: Ozurdex, 0.7mg dexamethasone

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Period Title: Overall Study
Started 14 13
Completed 14 13
Not Completed 0 0
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description

Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.

Ozurdex: Ozurdex, 0.7mg dexamethasone

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Total of all reporting groups
Overall Number of Baseline Participants 14 13 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  35.7%
3
  23.1%
8
  29.6%
>=65 years
9
  64.3%
10
  76.9%
19
  70.4%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants 13 participants 27 participants
68.8
(43 to 92)
74.3
(62 to 86)
71.3
(43 to 92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 13 participants 27 participants
Female
6
  42.9%
7
  53.8%
13
  48.1%
Male
8
  57.1%
6
  46.2%
14
  51.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants 13 participants 27 participants
14
 100.0%
13
 100.0%
27
 100.0%
1.Primary Outcome
Title The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm
Hide Description The change in visual acuity (number of ETDRS - Early Treatment Diabetic Retinopathy Study letters), at Month 6 as compared with baseline in each treatment arm
Time Frame Baseline - Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:

Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.

Ozurdex: Ozurdex, 0.7mg dexamethasone

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Overall Number of Participants Analyzed 14 13
Mean (Full Range)
Unit of Measure: Letters Gain/Loss
11.1
(-7 to 38)
16.1
(-2 to 39)
2.Primary Outcome
Title The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm
Hide Description Total Number of addiitonal Avastin injections during study- From baseline to Month 6
Time Frame Baseline - Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ozurdex & Avastin Avastin Only
Hide Arm/Group Description:

Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.

Ozurdex: Ozurdex, 0.7mg dexamethasone

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Overall Number of Participants Analyzed 14 13
Mean (Full Range)
Unit of Measure: Injections
2.5
(1 to 6)
5.1
(3 to 6)
3.Secondary Outcome
Title Change in Central Mean Thickness Based on OCT
Hide Description Change in Central Mean Thickness based on OCT from baseline to Month 6t
Time Frame Baseline to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:

Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.

Ozurdex: Ozurdex, 0.7mg dexamethasone

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Overall Number of Participants Analyzed 14 13
Mean (Full Range)
Unit of Measure: Microns on OCT
Initial OCT Measure at Basline
703
(344 to 1255)
790
(496 to 1183)
Final OCT measure at Month 6
353
(189 to 605)
408
(149 to 710)
Time Frame Adverse Events were collected for the study period of 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description

Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.

Ozurdex: Ozurdex, 0.7mg dexamethasone

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.

Avastin: Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.

All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Vincent A. Deramo, MD
Organization: Long Island Vitreoretinal Consultants
Phone: 5164660390 ext 222
Responsible Party: Vincent. A. Deramo, M.D., Long Island Vitreoretinal Consultants
ClinicalTrials.gov Identifier: NCT01231633     History of Changes
Other Study ID Numbers: IST CRVO 1118147
First Submitted: October 28, 2010
First Posted: November 1, 2010
Results First Submitted: August 22, 2017
Results First Posted: April 3, 2018
Last Update Posted: April 3, 2018