Trial Outcomes & Findings for A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus (NCT NCT01673191)

NCT ID: NCT01673191

Last Updated: 2017-04-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: 1 months
• Results posted on: 2017-04-05

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	DEX IMPLANT ARM n=26 Participants 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.	Topical Steroid/NSAID ARM n=11 Participants 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 n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=26 Participants	0 Participants n=11 Participants	0 Participants n=37 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=26 Participants	4 Participants n=11 Participants	16 Participants n=37 Participants
Age, Categorical >=65 years	14 Participants n=26 Participants	7 Participants n=11 Participants	21 Participants n=37 Participants
Age, Continuous	67.1 years STANDARD_DEVIATION 7.6 • n=26 Participants	68 years STANDARD_DEVIATION 8.4 • n=11 Participants	67.4 years STANDARD_DEVIATION 7.7 • n=37 Participants
Sex: Female, Male Female	14 Participants n=26 Participants	6 Participants n=11 Participants	20 Participants n=37 Participants
Sex: Female, Male Male	12 Participants n=26 Participants	5 Participants n=11 Participants	17 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	26 participants n=26 Participants	11 participants n=11 Participants	37 participants n=37 Participants
Best Corrected Visual Acuity	0.49 logMAR units STANDARD_DEVIATION 0.40 • n=26 Participants	0.32 logMAR units STANDARD_DEVIATION 0.22 • n=11 Participants	0.44 logMAR units STANDARD_DEVIATION 0.36 • n=37 Participants
Central Retinal Thickness	402.2 micrometers STANDARD_DEVIATION 149.8 • n=26 Participants	403.5 micrometers STANDARD_DEVIATION 156.2 • n=11 Participants	402.5 micrometers STANDARD_DEVIATION 149.5 • n=37 Participants
Intraocular Pressure	13.7 millimeters of mercury (mm Hg) STANDARD_DEVIATION 2.8 • n=26 Participants	14.4 millimeters of mercury (mm Hg) STANDARD_DEVIATION 2.5 • n=11 Participants	13.9 millimeters of mercury (mm Hg) STANDARD_DEVIATION 2.7 • n=37 Participants

PRIMARY outcome

Timeframe: 1 months

Outcome measures

Measure	DEX IMPLANT ARM n=26 Participants 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.	Topical Steroid/NSAID ARM n=11 Participants 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.
Mean Change in Best Corrected Visual Acuity	0.3 logMAR units Standard Deviation 0.2	0.33 logMAR units Standard Deviation 0.37

PRIMARY outcome

Timeframe: 2 months

Outcome measures

Measure	DEX IMPLANT ARM n=26 Participants 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.	Topical Steroid/NSAID ARM n=11 Participants 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.
Mean Change in Best Corrected Visual Acuity	0.34 logMAR units Standard Deviation 0.46	0.22 logMAR units Standard Deviation 0.18

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Measure	DEX IMPLANT ARM n=26 Participants 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.	Topical Steroid/NSAID ARM n=11 Participants 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.
Mean Change in Best Corrected Visual Acuity	0.34 logMAR units Standard Deviation 0.45	0.21 logMAR units Standard Deviation 0.18

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Measure	DEX IMPLANT ARM n=26 Participants 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.	Topical Steroid/NSAID ARM n=11 Participants 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.
Mean Change in Central Retinal Thickness	286.9 micrometers Standard Deviation 66.1	360.8 micrometers Standard Deviation 99.5

PRIMARY outcome

Timeframe: 2 months

Outcome measures

Measure	DEX IMPLANT ARM n=26 Participants 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.	Topical Steroid/NSAID ARM n=11 Participants 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.
Mean Change in Central Retinal Thickness	270.42 micrometers Standard Deviation 46.8	336 micrometers Standard Deviation 75.4

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Measure	DEX IMPLANT ARM n=26 Participants 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.	Topical Steroid/NSAID ARM n=11 Participants 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.
Mean Change in Central Retinal Thickness	318.7 micrometers Standard Deviation 103.2	341.1 micrometers Standard Deviation 74.6

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Measure	DEX IMPLANT ARM n=26 Participants 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.	Topical Steroid/NSAID ARM n=11 Participants 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.
Mean Change in Intraocular Pressure	14.9 millimeters of mercury (mm Hg) Standard Deviation 3.3	14.1 millimeters of mercury (mm Hg) Standard Deviation 3

Adverse Events

DEX IMPLANT ARM

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Topical Steroid/NSAID ARM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DEX IMPLANT ARM n=26 participants at risk 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.	Topical Steroid/NSAID ARM n=11 participants at risk 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.
Eye disorders Elevated Intraocular Pressure	3.8% 1/26 • 3 months	0.00% 0/11 • 3 months

Additional Information

Dr. Pravin Dugel

Retinal Consultants of Arizona

Phone: 602-222-2221

Email: PDugel@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place