Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

• Sponsor: Retina Macula Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01571232
• Collaborator: Allergan (Industry)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema; Non-proliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy	Drug: dexamethasone intravitreal implant; Drug: intravitreal bevacizumab	Phase 2

Detailed Description

This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema.
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ozurdex Patients in this group receive Ozurdex at initial visit and at month 4	Drug: dexamethasone intravitreal implant; Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5); Other Names: Ozurdex
Active Comparator: Avastin Patients in this group receive Avastin Q1 month for 5 months.	Drug: intravitreal bevacizumab; Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.; Other Names: Avastin

Outcome Measures

Primary Outcome Measures

1. The Change in Visual Acuity (Number of ETDRS Letters). [6 months]

   The measure the change in ETDRS letters for each treatment group from baseline to 6 months.

2. The Change in Central Foveal Thickness (Microns on High Resolution OCT). [6 months]

   The measure the change in central foveal thickness for each treatment group from baseline to 6 months.

Secondary Outcome Measures

1. The Change in Macular Leakage on Fluorescein Angiography From Baseline [6 months]

   To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.

2. The Change in Mean Macular Sensitivity on Microperimetry From Baseline [6 months]

   To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.

3. The Change in Mean Central Amplitude on Multi-focal ERG From Baseline. [6 months]

   To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Presence of NPDR or PDR as confirmed by fluorescein angiography

• Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks

• < 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit and following treatment with >= 2 intravitreal anti-VEGF injections

• Age 18 years or older

• ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25 to 20/800)

• Ability to provide written informed consent

• Capable of complying with study protocol.

Exclusion Criteria:

• Intraocular injection of steroid medication within prior 3 months

• Evidence of significant geographic atrophy on fluorescein angiography in the opinion of the treating physician

• Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual acuity in the opinion of the treating physician

• Prior vitrectomy surgery

• Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to day 1.

• Known history of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg.

• Patients who are pregnant.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Macula Institute	Torrance	California	United States	90503

Sponsors and Collaborators

• Retina Macula Institute
• Allergan

Investigators

• Principal Investigator: Ron P Gallemore, M.D, Ph.D, Retina Macula Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ron P. Gallemore, Physician and CEO of Retina Macula Institute, Retina Macula Institute
• ClinicalTrials.gov Identifier: NCT01571232
• Other Study ID Numbers: IIT-406
• First Posted: Apr 5, 2012
• Last Update Posted: Mar 30, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Ron P. Gallemore, Physician and CEO of Retina Macula Institute, Retina Macula Institute: Macular Edema; DME; PDR; NPDR; Ozurdex; Dexamethasone; Avastin; Bevacizumab
• Additional relevant MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Edema; Dexamethasone; Bevacizumab

Study Results

Participant Flow

Arm/Group Title	Ozurdex	Avastin
Arm/Group Description	Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Period Title: Overall Study
STARTED	10	10
COMPLETED	9	9
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Ozurdex	Avastin	Total
Arm/Group Description	Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.9 (1.8)	61.2 (2.9)	62.6 (1.7)
Sex: Female, Male (Count of Participants)
Female	5 50%	3 30%	8 40%
Male	5 50%	7 70%	12 60%

Outcome Measures

1. Primary Outcome

Title	The Change in Visual Acuity (Number of ETDRS Letters).
Description	The measure the change in ETDRS letters for each treatment group from baseline to 6 months.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ozurdex	Avastin
Arm/Group Description	Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Measure Participants	9	10
Baseline	67.8 (3.8)	71.9 (2.9)
Final Visit	69.6 (4.8)	72.9 (3.4)

2. Primary Outcome

Title	The Change in Central Foveal Thickness (Microns on High Resolution OCT).
Description	The measure the change in central foveal thickness for each treatment group from baseline to 6 months.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ozurdex	Avastin
Arm/Group Description	Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Measure Participants	9	10
Baseline	385.9 (43.0)	341.5 (11.3)
Final Visit	305.4 (9.1)	324.3 (10.9)

3. Secondary Outcome

Title	The Change in Macular Leakage on Fluorescein Angiography From Baseline
Description	To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Fluorescein angiography data were not collected.

Arm/Group Title	Ozurdex	Avastin
Arm/Group Description	Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Measure Participants	0	0

4. Secondary Outcome

Title	The Change in Mean Macular Sensitivity on Microperimetry From Baseline
Description	To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

One patient in the Ozurdex group withdrew consent, one patient in the Avastin group was lost to follow-up, and results were unattainable for two patients due to imaging difficulties.

Arm/Group Title	Ozurdex	Avastin
Arm/Group Description	Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Measure Participants	8	8
Baseline	5.6 (2.0)	10.7 (2.2)
Final Visit	7.4 (1.2)	10.7 (1.5)

5. Secondary Outcome

Title	The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.
Description	To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

One patient in the Ozurdex group withdrew consent, one patient in the Avastin group was lost to follow-up, and results were unattainable for three other patients due to testing difficulties.

Arm/Group Title	Ozurdex	Avastin
Arm/Group Description	Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Measure Participants	8	7
Baseline	27.8 (4.3)	34.4 (11.0)
Final Visit	40.9 (3.8)	30.3 (6.5)

Adverse Events

Time Frame	6 months
Arm/Group Title	Ozurdex		Avastin
Arm/Group Description	Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)		Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
All Cause Mortality
	Ozurdex		Avastin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Ozurdex		Avastin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Ozurdex		Avastin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		0/10 (0%)
Eye disorders
Elevated Intraocular Pressure	1/10 (10%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

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.