Trial Outcomes & Findings for Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study) (NCT NCT01613716)
NCT ID: NCT01613716
Last Updated: 2018-05-16
Results Overview
At 3 months, central retinal thickness as measured by optical coherence tomography will be measured
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
3 months
Results posted on
2018-05-16
Participant Flow
Participant milestones
| Measure |
Ozurdex
Subjects will receive Ozurdex injections and will be monitored for macular edema.
Ozurdex: Ozurdex .7 mg injected into the treated eye
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Ozurdex
Subjects will receive Ozurdex injections and will be monitored for macular edema.
Ozurdex: Ozurdex .7 mg injected into the treated eye
|
|---|---|
|
Overall Study
screen failures
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ozurdex
n=30 Participants
Subjects will receive Ozurdex injections and will be monitored for macular edema.
Ozurdex: Ozurdex .7 mg injected into the treated eye
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
61.63 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Optical Coherence Tomography was collected at 3 months. 22 of the patients were seen at month 3.
At 3 months, central retinal thickness as measured by optical coherence tomography will be measured
Outcome measures
| Measure |
Ozurdex
n=22 Participants
Subjects will receive Ozurdex injections and will be monitored for macular edema.
Ozurdex: Ozurdex .7 mg injected into the treated eye
|
|---|---|
|
Central Retinal Thickness
|
350 micrometers
Interval 208.0 to 483.0
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 23 of the participants were able to come in for their 3 month appointment per protocol
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.
Outcome measures
| Measure |
Ozurdex
n=23 Participants
Subjects will receive Ozurdex injections and will be monitored for macular edema.
Ozurdex: Ozurdex .7 mg injected into the treated eye
|
|---|---|
|
Visual Acuity
|
56 ETDRS
Interval 0.0 to 85.0
|
Adverse Events
Ozurdex
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ozurdex
n=30 participants at risk
Subjects will receive Ozurdex injections and will be monitored for macular edema.
Ozurdex: Ozurdex .7 mg injected into the treated eye
|
|---|---|
|
Eye disorders
Persistent Corneal Epithelial Defect
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Area of tractional retinal detachment versus retinoschisis surgery eye
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Gastrointestinal disorders
Peptic ulcers-hospitalized for stomach pain
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Infections and infestations
Root canal infection
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Removal of basal cell carcinoma
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Ozurdex placment on fovea
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Cardiac disorders
Myocardial infarction
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
Other adverse events
| Measure |
Ozurdex
n=30 participants at risk
Subjects will receive Ozurdex injections and will be monitored for macular edema.
Ozurdex: Ozurdex .7 mg injected into the treated eye
|
|---|---|
|
Eye disorders
Increase in intraocular pressure
|
23.3%
7/30 • Number of events 7 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Worsening of diabetic disease fellow eye
|
26.7%
8/30 • Number of events 19 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Increase in cataract surgical eye
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Increase in cataract fellow eye
|
20.0%
6/30 • Number of events 6 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
worsening of posterior capsular opacity
|
10.0%
3/30 • Number of events 3 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
worsening of posterior capsular opacity fellow eye
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory flu
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Infections and infestations
Dental infection
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Skin and subcutaneous tissue disorders
Poison Ivy rash
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Cardiac disorders
Tachycardia
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Musculoskeletal and connective tissue disorders
broken patella
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Reproductive system and breast disorders
Bronchitis
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
increased cystoid macular edema study eye
|
16.7%
5/30 • Number of events 7 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Nervous system disorders
Transient Ischemic Avent
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Epithelial defect study eye
|
13.3%
4/30 • Number of events 4 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Increased itching both eyes
|
13.3%
4/30 • Number of events 4 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Increase in pain study eye
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Increased diabetic retinopathy study eye
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Increase of dryness of the eyes
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Trouble breathing
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Cardiac disorders
Cartoid blockage
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
loss of vision fellow eye
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
small choroidal study eye
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Vitreous hemorrhage study eye
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
General disorders
Syncope after injection
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Trouble reading
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Injury, poisoning and procedural complications
Nausea, vomiting diarrhea,dehydration
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Nervous system disorders
Worsening of Parkinson's tremors
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Immune system disorders
Sarcoidosis Flare
|
3.3%
1/30 • Number of events 2 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Foreign body sensation of eyes
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Injury, poisoning and procedural complications
Injury to hip an back
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Subconjunctival hemorrhage fellow eye
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Gastrointestinal disorders
Digestion issues
|
3.3%
1/30 • Number of events 2 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Infections and infestations
Sinus infection
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Increased floaters fellow eye
|
6.7%
2/30 • Number of events 2 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Decreased television vision fellow eye
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Glare with vision at night
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
|
Eye disorders
Tearing in both eyes
|
3.3%
1/30 • Number of events 1 • Adverse events were collected from point of screening until their last visit at 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place