Trial Outcomes & Findings for Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or Moderate Proliferative Diabetic Retinopathy (NCT NCT00511875)
NCT ID: NCT00511875
Last Updated: 2018-11-02
Results Overview
Change in dark adaptation is measured as dark adaptation time at baseline measured in minutes minus dark adaptation time measured at 24 months
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Baseline and 24 months
Results posted on
2018-11-02
Participant Flow
Participant milestones
| Measure |
Doxycycline Monohydrate
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
Placebo
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
10
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Doxycycline Monohydrate
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
Placebo
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Missing variables
|
1
|
0
|
Baseline Characteristics
Evaluation of Doxycycline Verses Placebo for the Treatment of Severe Nonproliferative or Mild or Moderate Proliferative Diabetic Retinopathy
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=15 Participants
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 monthsPopulation: Of 10 participants who completed doxycycline treatment, usable endpoint data is only available for 8.
Change in dark adaptation is measured as dark adaptation time at baseline measured in minutes minus dark adaptation time measured at 24 months
Outcome measures
| Measure |
Placebo
n=15 Participants
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=8 Participants
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
|---|---|---|
|
Change in Dark Adaptation, Rod Intercept
|
0.3 minutes
Standard Deviation 3.3
|
-0.3 minutes
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Baseline and 24 monthsChange in photopic visual fields between baseline and 24 months
Outcome measures
| Measure |
Placebo
n=15 Participants
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=10 Participants
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
|---|---|---|
|
Change in Photopic Visual Field
Foveal Sensitivity
|
-0.8 dB
Standard Deviation 12.2
|
-0.8 dB
Standard Deviation 1.3
|
|
Change in Photopic Visual Field
Mean Sensitivity
|
-0.74 dB
Standard Deviation 1.90
|
-1.0 dB
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 24 monthsChange in Frequency Doubling Perimetry (FDP) from baseline, shown as mean and foveal (center of retina) scores
Outcome measures
| Measure |
Placebo
n=15 Participants
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=10 Participants
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
|---|---|---|
|
Change in Frequency Doubling Perimetry (FDP)
Foveal Sensitivity
|
-1.9 dB
Standard Deviation 3.8
|
1.8 dB
Standard Deviation 3.6
|
|
Change in Frequency Doubling Perimetry (FDP)
Mean FDP sensitivity
|
-0.7 dB
Standard Deviation 3.9
|
0.7 dB
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Baseline and 24 monthsChange in ETDRS visual acuity letter score from baseline. ETDRS is measured on a scale of 0 to 70 where 0 means inability to see anything on the chart and 70 is normal (20/20) acuity.
Outcome measures
| Measure |
Placebo
n=15 Participants
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=11 Participants
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
|---|---|---|
|
Change in Early Treatment Diabetic Retinopathy Study (ETDRS)
|
0.3 score on a scale
Standard Deviation 8.8
|
0.2 score on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsChange in central subfield thickness from baseline
Outcome measures
| Measure |
Placebo
n=15 Participants
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=11 Participants
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
|---|---|---|
|
Change in Central Subfield Thickness
|
-1.5 μm
Standard Deviation 14.9
|
4.8 μm
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: 24 monthsChange in macular volume from baseline
Outcome measures
| Measure |
Placebo
n=15 Participants
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=11 Participants
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
|---|---|---|
|
Change in Macular Volume
|
-0.2 mm^3
Standard Deviation 0.3
|
-0.1 mm^3
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 24 monthsChange in Central Retinal Artery Equivalent (CRAE) diameter from baseline
Outcome measures
| Measure |
Placebo
n=15 Participants
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=11 Participants
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
|---|---|---|
|
Change in Central Retinal Artery Equivalent (CRAE) Diameter
|
-0.49 μm
Standard Deviation 12
|
0.17 μm
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 24 monthsChange in Central Retinal Vein Equivalent (CRVE) diameter from baseline
Outcome measures
| Measure |
Placebo
n=15 Participants
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=11 Participants
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
|---|---|---|
|
Change in Central Retinal Vein Equivalent (CRVE) Diameter
|
-6.3 μm
Standard Deviation 19
|
-6.6 μm
Standard Deviation 18
|
SECONDARY outcome
Timeframe: 24 monthsChange in arteriovenous ratio diameter from baseline
Outcome measures
| Measure |
Placebo
n=15 Participants
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=11 Participants
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
|---|---|---|
|
Change in Arteriovenous Ratio Diameter
|
0.013 ratio
Standard Deviation 0.057
|
0.013 ratio
Standard Deviation 0.056
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Doxycycline Monohydrate
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=15 participants at risk
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=15 participants at risk
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
|---|---|---|
|
Injury, poisoning and procedural complications
motor vehicle accident
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Blood and lymphatic system disorders
elevated serum creatinine level
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Eye disorders
persistent vitreous hemorrhage
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Nervous system disorders
concussion of brain
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Gastrointestinal disorders
umbilical hernia
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Injury, poisoning and procedural complications
skull fracture
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
Other adverse events
| Measure |
Placebo
n=15 participants at risk
stratified equally to placebo taken once daily for 24 months
placebo: placebo taken once daily for 24 months
|
Doxycycline Monohydrate
n=15 participants at risk
stratified equally to doxycycline monohydrate 50mg taken once daily for 24 months
doxycycline monohydrate: 50mg once daily for 24 months
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
abscess molar tooth (root canal)
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Immune system disorders
allergic reaction - reason unknown
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Immune system disorders
allergies (seasonal)
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
ankle sprain (right)
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Psychiatric disorders
anxiety (mild)
|
6.7%
1/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
back pain (possibly with neck pain)
|
13.3%
2/15 • 24 months
|
13.3%
2/15 • 24 months
|
|
Renal and urinary disorders
benign prostatic hyperplasia
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Skin and subcutaneous tissue disorders
bilateral blepharitis
|
20.0%
3/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Injury, poisoning and procedural complications
broken right foot
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
13.3%
2/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Nervous system disorders
burning sensation in fingers
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Surgical and medical procedures
carpal tunnel surgery (left)
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Eye disorders
cataract
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Surgical and medical procedures
cataract extraction
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Eye disorders
chalazion left eye
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
chest cold
|
0.00%
0/15 • 24 months
|
13.3%
2/15 • 24 months
|
|
Cardiac disorders
congestive heart failure
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
20.0%
3/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Nervous system disorders
decreased smell
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Nervous system disorders
decreased taste
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Psychiatric disorders
depression
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Gastrointestinal disorders
diarrhea
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Eye disorders
diplopia
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Skin and subcutaneous tissue disorders
dry rash
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Skin and subcutaneous tissue disorders
epidermoid cyst
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Eye disorders
epiretinal fibrosis
|
6.7%
1/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Eye disorders
epiretinal membrane, (slight) right eye
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Injury, poisoning and procedural complications
fall (cause of injuries unknown)
|
0.00%
0/15 • 24 months
|
13.3%
2/15 • 24 months
|
|
General disorders
fatigue
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Eye disorders
flashes right eye
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Eye disorders
floaters left eye
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Infections and infestations
flu
|
26.7%
4/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
fluid on left knee
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Gastrointestinal disorders
gastric ulcer
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Metabolism and nutrition disorders
gout
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
head cold
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Nervous system disorders
headaches
|
6.7%
1/15 • 24 months
|
13.3%
2/15 • 24 months
|
|
Renal and urinary disorders
high creatinine
|
13.3%
2/15 • 24 months
|
13.3%
2/15 • 24 months
|
|
Eye disorders
high intraocular pressure
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Renal and urinary disorders
high urine albumin
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Metabolism and nutrition disorders
hyperlipidemia
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Cardiac disorders
hypertension
|
26.7%
4/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Metabolism and nutrition disorders
hypoglycemic episode
|
20.0%
3/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
impacted wisdom tooth
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Eye disorders
increased glare
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Infections and infestations
infection
|
13.3%
2/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Renal and urinary disorders
cystitis
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Surgical and medical procedures
left distal tibia/fibula fracture and surgery
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
leg pain (both)
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Blood and lymphatic system disorders
leukocytosis
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Blood and lymphatic system disorders
low potassium
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Gastrointestinal disorders
nausea
|
6.7%
1/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
neck stiffness
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Eye disorders
peripheral retinopathy (PDR)
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Eye disorders
neovascularization
|
33.3%
5/15 • 24 months
|
20.0%
3/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
nocturnal leg cramps
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Eye disorders
ocular hypertension right eye
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Surgical and medical procedures
oral surgery
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
pain in right shoulder
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Eye disorders
purulent conjunctivitis
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Injury, poisoning and procedural complications
post-traumatic right shoulder adhesive capsulitis
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Eye disorders
pre-retinal hemorrhage
|
6.7%
1/15 • 24 months
|
13.3%
2/15 • 24 months
|
|
Renal and urinary disorders
prostatitis
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Immune system disorders
pruritus during fluorescein angiography
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Eye disorders
punctate keratopathy
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Product Issues
received dentures
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
right ankle pain
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
right ankle sprain
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
right foot pain
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Injury, poisoning and procedural complications
right shoulder fracture
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Eye disorders
shallow traction retinal detachment
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
sinus infection
|
20.0%
3/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
sleep apnea
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Infections and infestations
sore throat
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Infections and infestations
stomach virus
|
0.00%
0/15 • 24 months
|
13.3%
2/15 • 24 months
|
|
Surgical and medical procedures
tendon release surgery (right hand)
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Surgical and medical procedures
tendon release surgery (thumb)
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Surgical and medical procedures
tooth extraction
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Surgical and medical procedures
upper and lower teeth extracted
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
6.7%
1/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Renal and urinary disorders
urinary tract infection
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Nervous system disorders
vertigo
|
6.7%
1/15 • 24 months
|
0.00%
0/15 • 24 months
|
|
Eye disorders
vitrectromy
|
13.3%
2/15 • 24 months
|
6.7%
1/15 • 24 months
|
|
Eye disorders
vitreous hemorrhage
|
13.3%
2/15 • 24 months
|
13.3%
2/15 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place