A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus

• Sponsor: Retinal Consultants of Arizona (Other)
• Overall Status: Completed
• CT.gov ID: NCT01673191
• Collaborator: Allergan (Industry)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema; Diabetes Mellitus	Drug: Dexamethasone intravitreal implant; Drug: Steroid plus NSAID eye drop combination therapy	Phase 2

Detailed Description

The objective of this study is to assess the safety and efficacy of the OZURDEX® intraocular implant in patients with diabetes mellitus, who develop macular edema after cataract surgery

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OZURDEX intraocular implant OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg	Drug: Dexamethasone intravitreal implant; Other Names: OZURDEX
Active Comparator: Steroid plus NSAID eye drop combination therapy NSAID eye drop: Acular LS Steriod eye drop: Pred Forte	Drug: Steroid plus NSAID eye drop combination therapy; Other Names: Acular LS and Pred Forte

Outcome Measures

Primary Outcome Measures

1. Mean Change in Best Corrected Visual Acuity [1 months]

2. Mean Change in Best Corrected Visual Acuity [2 months]

3. Mean Change in Best Corrected Visual Acuity [3 months]

4. Mean Change in Central Retinal Thickness [1 month]

5. Mean Change in Central Retinal Thickness [2 months]

6. Mean Change in Central Retinal Thickness [3 months]

7. Mean Change in Intraocular Pressure [3 months]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patient has diagnosis of Diabetes Mellitus, Type I or II.

• Patient has experienced the development of macular edema following cataract surgery in at least one eye.

• Patient has had cataract surgery within 90 days prior to the screening visit.

Exclusion Criteria:

• Patient has other significant ocular disease in study eye, including glaucoma.

• Patient has any active infection in the study eye.

• Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure, uncontrolled diabetes mellitus).

• Patient has experienced a significant increase in intraocular pressure following a prior treatment with topical or intravitreal steroidal medication.

• Patient has received the OZURDEX® implant before in the study eye.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retinal Consultants of Arizona	Phoenix	Arizona	United States	85014

Sponsors and Collaborators

• Retinal Consultants of Arizona
• Allergan

Investigators

• Principal Investigator: Pravin U Dugel, MD, Retinal Consultants of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Retinal Consultants of Arizona
• ClinicalTrials.gov Identifier: NCT01673191
• Other Study ID Numbers: RCA2012
• First Posted: Aug 27, 2012
• Last Update Posted: Apr 5, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Macular Edema; Diabetes Mellitus; Dexamethasone; Prednisolone acetate; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	OZURDEX Intraocular Implant	Steroid Plus NSAID Eye Drop Combination Therapy
Arm/Group Description	OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg Dexamethasone intravitreal implant	NSAID eye drop: Acular LS Steriod eye drop: Pred Forte Steroid plus NSAID eye drop combination therapy
Period Title: Overall Study
STARTED	26	11
COMPLETED	26	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	DEX IMPLANT ARM	Topical Steroid/NSAID ARM	Total
Arm/Group Description	Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.	Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.	Total of all reporting groups
Overall Participants	26	11	37
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 46.2%	4 36.4%	16 43.2%
>=65 years	14 53.8%	7 63.6%	21 56.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.1 (7.6)	68 (8.4)	67.4 (7.7)
Sex: Female, Male (Count of Participants)
Female	14 53.8%	6 54.5%	20 54.1%
Male	12 46.2%	5 45.5%	17 45.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	26 100%	11 100%	37 100%
Best Corrected Visual Acuity (logMAR units) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [logMAR units]	0.49 (0.40)	0.32 (0.22)	0.44 (0.36)
Central Retinal Thickness (micrometers) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [micrometers]	402.2 (149.8)	403.5 (156.2)	402.5 (149.5)
Intraocular Pressure (millimeters of mercury (mm Hg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeters of mercury (mm Hg)]	13.7 (2.8)	14.4 (2.5)	13.9 (2.7)

Outcome Measures

1. Primary Outcome

Title	Mean Change in Best Corrected Visual Acuity
Time Frame	1 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DEX IMPLANT ARM	Topical Steroid/NSAID ARM
Arm/Group Description	Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.	Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
Measure Participants	26	11
Mean (Standard Deviation) [logMAR units]	0.3 (0.2)	0.33 (0.37)

2. Primary Outcome

Title	Mean Change in Best Corrected Visual Acuity
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DEX IMPLANT ARM	Topical Steroid/NSAID ARM
Arm/Group Description	Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.	Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
Measure Participants	26	11
Mean (Standard Deviation) [logMAR units]	0.34 (0.46)	0.22 (0.18)

3. Primary Outcome

Title	Mean Change in Best Corrected Visual Acuity
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DEX IMPLANT ARM	Topical Steroid/NSAID ARM
Arm/Group Description	Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.	Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
Measure Participants	26	11
Mean (Standard Deviation) [logMAR units]	0.34 (0.45)	0.21 (0.18)

4. Primary Outcome

Title	Mean Change in Central Retinal Thickness
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DEX IMPLANT ARM	Topical Steroid/NSAID ARM
Arm/Group Description	Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.	Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
Measure Participants	26	11
Mean (Standard Deviation) [micrometers]	286.9 (66.1)	360.8 (99.5)

5. Primary Outcome

Title	Mean Change in Central Retinal Thickness
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DEX IMPLANT ARM	Topical Steroid/NSAID ARM
Arm/Group Description	Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.	Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
Measure Participants	26	11
Mean (Standard Deviation) [micrometers]	270.42 (46.8)	336 (75.4)

6. Primary Outcome

Title	Mean Change in Central Retinal Thickness
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DEX IMPLANT ARM	Topical Steroid/NSAID ARM
Arm/Group Description	Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.	Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
Measure Participants	26	11
Mean (Standard Deviation) [micrometers]	318.7 (103.2)	341.1 (74.6)

7. Primary Outcome

Title	Mean Change in Intraocular Pressure
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DEX IMPLANT ARM	Topical Steroid/NSAID ARM
Arm/Group Description	Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.	Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
Measure Participants	26	11
Mean (Standard Deviation) [millimeters of mercury (mm Hg)]	14.9 (3.3)	14.1 (3)

Adverse Events

Time Frame	3 months
Arm/Group Title	DEX IMPLANT ARM		Topical Steroid/NSAID ARM
Arm/Group Description	Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.		Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
All Cause Mortality
	DEX IMPLANT ARM		Topical Steroid/NSAID ARM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/11 (0%)
Serious Adverse Events
	DEX IMPLANT ARM		Topical Steroid/NSAID ARM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	DEX IMPLANT ARM		Topical Steroid/NSAID ARM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/26 (3.8%)		0/11 (0%)
Eye disorders
Elevated Intraocular Pressure	1/26 (3.8%)		0/11 (0%)

Limitations/Caveats

Limitations of our study include a small sample size and short-term follow up. Additional studies are needed to determine whether combination therapy with other treatments would be beneficial to patients.

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.