Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01613716
• Collaborator: Allergan (Industry)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 55.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study will examine the use of the dexamethasone implant (Ozurdex) in patients with macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will be placed in the eye. Patients will be followed for 1 year.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema; Epiretinal Membrane	Drug: Ozurdex	Phase 4

Detailed Description

The purpose of this study to examine the use of Ozurdex in patients who are undergoing pars plana vitrectomy for macular edema due to preretinal membranes. Specifically, we will examine its effect on macular edema (measured by OCT), and visual recovery (measured by visual acuity). We will examine its use in patients who underwent pars plana vitrectomy for macular edema with associated taut membrane. This will be a prospective pilot study with patients to receive an Ozurdex implant at the time of vitrectomy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)
• Actual Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ozurdex Subjects will receive Ozurdex injections and will be monitored for macular edema.	Drug: Ozurdex; Ozurdex .7 mg injected into the treated eye; Other Names: Dexamethasone

Outcome Measures

Primary Outcome Measures

1. Central Retinal Thickness [3 months]

   At 3 months, central retinal thickness as measured by optical coherence tomography will be measured

2. Visual Acuity [3 months]

   ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients who are undergoing pars plana vitrectomy for:

• Epiretinal membrane/vitreomacular traction or

• Diabetic macular edema

1. Patients with macular edema as measured by OCT (at least 250 um central subfoveal thickness)

2. Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English.

3. Age between 18-85 years old

Exclusion Criteria:

1. Age < 18 years or > 85 years

2. History of macular edema due to diseases other than those in the inclusion criteria in the study eye

• History of active inflammatory eye disease (uveitis) (within 3 months)

• History of ocular malignancy and/or ocular/orbital irradiation

• History of recent retinal vein occlusion (within 6 months)

• History of neovascular age-related macular degeneration or choroidal neovascular membrane [

• History of juxtafoveal telangiectasia

• History of Coat's disease

• History central serous choroidoretinopathy

• History of previous infectious retinitis (toxoplasmosis, acute retinal necrosis, tuberculosis, etc)

1. Patients with a history of intraocular infection in the study eye (i.e. viral retinitis, endophthalmitis)

2. Patients who are cognitively impaired or those who are unable to provide informed written consent

3. Patients with a history of glaucoma in the study eye (defined as increased cup to disc ratio with associated nerve damage. Patients with ocular hypertension controlled by topical glaucoma drops (maximum 3) will not be excluded).

4. Patient with recent intravitreal injections of steroids or anti-VEGF medications in the study eye (within past 4 weeks).

5. Patients with recent periocular steroid injection (within past 4 weeks) in the study eye

6. Patients on topical NSAIDS drops (patient will be eligible if they discontinue use of topical NSAIDs at time of study enrollment) in the study eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cole Eye Institute, Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic
• Allergan

Investigators

• Principal Investigator: Sunil Srivastava, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunil Srivastava, PI, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT01613716
• Other Study ID Numbers: 115200
• First Posted: Jun 7, 2012
• Last Update Posted: May 16, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Sunil Srivastava, PI, The Cleveland Clinic: Diabetes; Macular Edema; Epiretinal Membrane; Vitrectomy
• Additional relevant MeSH terms: Macular Edema; Epiretinal Membrane; Edema; Dexamethasone

Study Results

Participant Flow

Arm/Group Title	Ozurdex
Arm/Group Description	Subjects will receive Ozurdex injections and will be monitored for macular edema. Ozurdex: Ozurdex .7 mg injected into the treated eye
Period Title: Overall Study
STARTED	30
COMPLETED	23
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Ozurdex
Arm/Group Description	Subjects will receive Ozurdex injections and will be monitored for macular edema. Ozurdex: Ozurdex .7 mg injected into the treated eye
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 100%
>=65 years	0 0%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61.63
Sex: Female, Male (Count of Participants)
Female	12 40%
Male	18 60%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Central Retinal Thickness
Description	At 3 months, central retinal thickness as measured by optical coherence tomography will be measured
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Optical Coherence Tomography was collected at 3 months. 22 of the patients were seen at month 3.

Arm/Group Title	Ozurdex
Arm/Group Description	Subjects will receive Ozurdex injections and will be monitored for macular edema. Ozurdex: Ozurdex .7 mg injected into the treated eye
Measure Participants	22
Median (Full Range) [micrometers]	350

2. Primary Outcome

Title	Visual Acuity
Description	ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

23 of the participants were able to come in for their 3 month appointment per protocol

Arm/Group Title	Ozurdex
Arm/Group Description	Subjects will receive Ozurdex injections and will be monitored for macular edema. Ozurdex: Ozurdex .7 mg injected into the treated eye
Measure Participants	23
Median (Full Range) [ETDRS]	56

Adverse Events

Time Frame	Adverse events were collected from point of screening until their last visit at 12 months.
Arm/Group Title	Ozurdex
Arm/Group Description	Subjects will receive Ozurdex injections and will be monitored for macular edema. Ozurdex: Ozurdex .7 mg injected into the treated eye
All Cause Mortality
	Ozurdex
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Ozurdex
	Affected / at Risk (%)	# Events
Total	7/30 (23.3%)
Cardiac disorders
Myocardial infarction	1/30 (3.3%)	1
Eye disorders
Persistent Corneal Epithelial Defect	1/30 (3.3%)	1
Area of tractional retinal detachment versus retinoschisis surgery eye	1/30 (3.3%)	1
Ozurdex placment on fovea	1/30 (3.3%)	1
Gastrointestinal disorders
Peptic ulcers-hospitalized for stomach pain	1/30 (3.3%)	1
Infections and infestations
Root canal infection	1/30 (3.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Removal of basal cell carcinoma	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	Ozurdex
	Affected / at Risk (%)	# Events
Total	27/30 (90%)
Cardiac disorders
Tachycardia	1/30 (3.3%)	1
Cartoid blockage	1/30 (3.3%)	1
Eye disorders
Increase in cataract surgical eye	2/30 (6.7%)	2
Increase in cataract fellow eye	6/30 (20%)	6
Increase in intraocular pressure	7/30 (23.3%)	7
Worsening of diabetic disease fellow eye	8/30 (26.7%)	19
worsening of posterior capsular opacity	3/30 (10%)	3
worsening of posterior capsular opacity fellow eye	1/30 (3.3%)	1
increased cystoid macular edema study eye	5/30 (16.7%)	7
Epithelial defect study eye	4/30 (13.3%)	4
Increased itching both eyes	4/30 (13.3%)	4
Increase in pain study eye	2/30 (6.7%)	2
Increased diabetic retinopathy study eye	1/30 (3.3%)	1
Increase of dryness of the eyes	2/30 (6.7%)	2
loss of vision fellow eye	1/30 (3.3%)	1
small choroidal study eye	1/30 (3.3%)	1
Vitreous hemorrhage study eye	2/30 (6.7%)	2
Trouble reading	1/30 (3.3%)	1
Foreign body sensation of eyes	1/30 (3.3%)	1
Subconjunctival hemorrhage fellow eye	1/30 (3.3%)	1
Increased floaters fellow eye	2/30 (6.7%)	2
Decreased television vision fellow eye	1/30 (3.3%)	1
Glare with vision at night	1/30 (3.3%)	1
Tearing in both eyes	1/30 (3.3%)	1
Gastrointestinal disorders
Diarrhea	1/30 (3.3%)	1
Digestion issues	1/30 (3.3%)	2
General disorders
Syncope after injection	1/30 (3.3%)	1
Immune system disorders
Sarcoidosis Flare	1/30 (3.3%)	2
Infections and infestations
Dental infection	1/30 (3.3%)	1
Sinus infection	2/30 (6.7%)	2
Injury, poisoning and procedural complications
Motor vehicle accident	2/30 (6.7%)	2
Nausea, vomiting diarrhea,dehydration	1/30 (3.3%)	1
Injury to hip an back	1/30 (3.3%)	1
Musculoskeletal and connective tissue disorders
broken patella	1/30 (3.3%)	1
Nervous system disorders
Transient Ischemic Avent	1/30 (3.3%)	1
Worsening of Parkinson's tremors	1/30 (3.3%)	1
Reproductive system and breast disorders
Bronchitis	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
respiratory flu	1/30 (3.3%)	1
Trouble breathing	1/30 (3.3%)	1
Skin and subcutaneous tissue disorders
Poison Ivy rash	1/30 (3.3%)	1

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.