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

• Sponsor: Long Island Vitreoretinal Consultants (Other)
• Overall Status: Completed
• CT.gov ID: NCT01231633
• Collaborator: (none)
• Enrollment: 27
• Locations: 4
• Arms: 2
• Duration (Months): 48
• Patients Per Site: 6.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).

Condition or Disease	Intervention/Treatment	Phase
Macular Edema; Central Retinal Vein Occlusion	Drug: Ozurdex; Drug: Avastin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.	Drug: Ozurdex; Ozurdex, 0.7mg dexamethasone; Other Names: Dexamethasone implant ; Drug: Avastin; Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.; Other Names: Avastin, bevacizumab
Active Comparator: Group 2 Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.	Drug: Avastin; Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.; Other Names: Avastin, bevacizumab

Outcome Measures

Primary Outcome Measures

1. 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 [Baseline - Month 6]

   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

2. The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm [Baseline - Month 6]

   Total Number of addiitonal Avastin injections during study- From baseline to Month 6

Secondary Outcome Measures

1. Change in Central Mean Thickness Based on OCT [Baseline to 6 Months]

   Change in Central Mean Thickness based on OCT from baseline to Month 6t

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Presence of central retinal vein occlusion (CRVO)

• Age 18 years or older

• ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800

• OCT Central foveal thickness >250 microns

• Negative pregnancy test for women of childbearing potential

• Ability to provide written informed consent

• Capable of complying with study protocol

Exclusion Criteria:

• History of glaucoma in the study eye with intraocular pressure >21mmHg on more than one topical medication. Combination drugs are considered more than one medication

• History of steroid-related glaucoma (steroid response)

• Previous intraocular injection of steroid medication within 90 days

• Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days

• Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician

• Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days

• Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician

• Dense cataract that precludes clinical examination and retinal imaging of the retina

• History of allergy to dexamethasone, bevacizumab, betadine

• Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician

• Unwilling or unable to follow or comply with all study related procedures

• Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Vitreous Center	Toms River	New Jersey	United States	08755
2	Long Island Vitreoretinal Consultants	Great Neck	New York	United States	11021
3	Long Island Vitreoretinal Consultants	Hauppauge	New York	United States	11788
4	Long Island Vitreoretinal Consultants	Riverhead	New York	United States	11901

Sponsors and Collaborators

• Long Island Vitreoretinal Consultants

Investigators

• Principal Investigator: Vincent A Deramo, M.D, Long Island Vitreoretinal Consultants

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vincent. A. Deramo, M.D., Prinicipal Investigator, Long Island Vitreoretinal Consultants
• ClinicalTrials.gov Identifier: NCT01231633
• Other Study ID Numbers: IST CRVO 1118147
• First Posted: Nov 1, 2010
• Last Update Posted: Apr 3, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by Vincent. A. Deramo, M.D., Prinicipal Investigator, Long Island Vitreoretinal Consultants: Macular Edema; Central Retinal Vein Occlusion
• Additional relevant MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema; Dexamethasone; Bevacizumab

Study Results

Participant Flow

Arm/Group Title	Ozurdex & Avastin	Avastin Only
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

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Total
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 Participants	14	13	27
Age (Count of Participants)
<=18 years	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 (years) [Mean (Full Range) ]
Mean (Full Range) [years]	68.8	74.3	71.3
Sex: Female, Male (Count of Participants)
Female	6 42.9%	7 53.8%	13 48.1%
Male	8 57.1%	6 46.2%	14 51.9%
Region of Enrollment (Count of Participants)
United States	14 100%	13 100%	27 100%

Outcome Measures

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
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.
Measure Participants	14	13
Mean (Full Range) [Letters Gain/Loss]	11.1	16.1

2. Primary Outcome

Title	The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm
Description	Total Number of addiitonal Avastin injections during study- From baseline to Month 6
Time Frame	Baseline - Month 6

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ozurdex & Avastin	Avastin Only
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.
Measure Participants	14	13
Mean (Full Range) [Injections]	2.5	5.1

3. Secondary Outcome

Title	Change in Central Mean Thickness Based on OCT
Description	Change in Central Mean Thickness based on OCT from baseline to Month 6t
Time Frame	Baseline to 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
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.
Measure Participants	14	13
Initial OCT Measure at Basline	703	790
Final OCT measure at Month 6	353	408

Adverse Events

Time Frame	Adverse Events were collected for the study period of 6 months.
Arm/Group Title	Group 1		Group 2
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/13 (0%)
Serious Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.