Trial Outcomes & Findings for Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy (NCT NCT00917553)
NCT ID: NCT00917553
Last Updated: 2018-11-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Baseline and 24 months
Results posted on
2018-11-30
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
Placebo: Cellulose Placebo Capsule
|
Doxycycline Monohydrate
doxycycline monohydrate: 50 mg
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
Placebo: Cellulose Placebo Capsule
|
Doxycycline Monohydrate
doxycycline monohydrate: 50 mg
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy
Baseline characteristics by cohort
| Measure |
Placebo
n=17 Participants
Placebo
Placebo: Cellulose Placebo Capsule
|
Doxycycline Monohydrate
n=16 Participants
doxycycline monohydrate: 50 mg
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.76 years
STANDARD_DEVIATION 7.61 • n=5 Participants
|
58.44 years
STANDARD_DEVIATION 12.96 • n=7 Participants
|
57.57 years
STANDARD_DEVIATION 10.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 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
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 monthsPopulation: Two participants in the placebo group and one in the doxycycline group were unavailable for 24 month results.
Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo
Placebo: Cellulose Placebo Capsule
|
Doxycycline Monohydrate
n=15 Participants
doxycycline monohydrate: 50 mg
|
|---|---|---|
|
The Mean Change in the Foveal Sensitivity of Matrix Frequency Doubling Perimetry (FDP) From Baseline in the Treated Group Compared to the Placebo Group
|
2.80 dB
Standard Deviation 3.80
|
0.13 dB
Standard Deviation 4.45
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsAnatomic outcomes were assessed through optical coherence. Positive numbers indicate increases in thickness.
Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo
Placebo: Cellulose Placebo Capsule
|
Doxycycline Monohydrate
n=15 Participants
doxycycline monohydrate: 50 mg
|
|---|---|---|
|
Change Thickness Thickness
Central subfield thickness
|
17.5 µm
Standard Deviation 27.3
|
21.3 µm
Standard Deviation 72.5
|
|
Change Thickness Thickness
Center point thickness
|
25.6 µm
Standard Deviation 41.7
|
26.1 µm
Standard Deviation 81.1
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsOutcome measures
| Measure |
Placebo
n=15 Participants
Placebo
Placebo: Cellulose Placebo Capsule
|
Doxycycline Monohydrate
n=15 Participants
doxycycline monohydrate: 50 mg
|
|---|---|---|
|
Change in Macular Volume
|
0.06 mm^3
Standard Deviation 0.34
|
0.23 mm^3
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline to 24 monthsParticipants are shown categorically by whether they reached PDR, or whether their diabetic retinopathy levels changed by one grade or more, as analyzed by fundus photography.
Outcome measures
| Measure |
Placebo
n=17 Participants
Placebo
Placebo: Cellulose Placebo Capsule
|
Doxycycline Monohydrate
n=16 Participants
doxycycline monohydrate: 50 mg
|
|---|---|---|
|
Number of Participants With Progression to PDR, and Single or Multiple Step Progression in ETDRS Diabetic Retinopathy Severity Level
>=3 severity level ETDRS
|
0 Participants
|
1 Participants
|
|
Number of Participants With Progression to PDR, and Single or Multiple Step Progression in ETDRS Diabetic Retinopathy Severity Level
Progressed to PDR
|
0 Participants
|
1 Participants
|
|
Number of Participants With Progression to PDR, and Single or Multiple Step Progression in ETDRS Diabetic Retinopathy Severity Level
>=1 severity level ETDRS
|
9 Participants
|
7 Participants
|
|
Number of Participants With Progression to PDR, and Single or Multiple Step Progression in ETDRS Diabetic Retinopathy Severity Level
>=2 severity level ETDRS
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 24 monthsAny participants who developed vitreous or preretinal hemorrhage were counted. Had there been any preretinal hemorrhages (a subcategory of vitreous hemorrhage) these would have been shown as a separate row.
Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo
Placebo: Cellulose Placebo Capsule
|
Doxycycline Monohydrate
n=15 Participants
doxycycline monohydrate: 50 mg
|
|---|---|---|
|
Number of Participants Who Developed Vitreous or Preretinal Hemorrhage
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Doxycycline Monohydrate
Serious events: 8 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=17 participants at risk
Placebo
Placebo: Cellulose Placebo Capsule
|
Doxycycline Monohydrate
n=16 participants at risk
doxycycline monohydrate: 50 mg
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
dysphagia
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Infections and infestations
E. Coli sepsis/acute kidney injury
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Cardiac disorders
probable TIA
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
arthritis - total knee arthroplasty
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Metabolism and nutrition disorders
diabetic ketoacidosis
|
5.9%
1/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Cardiac disorders
angina/non-anginal chest pain
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
General disorders
hospitalization - noncardiac chest pain
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Renal and urinary disorders
chronic renal failure
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Psychiatric disorders
confusional state
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Metabolism and nutrition disorders
uncontrolled hyperglycemia
|
11.8%
2/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Cardiac disorders
chronic systolic heart failure
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
right foot Charcot arthropathy
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Cardiac disorders
Mobitz type 1
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Cardiac disorders
accelerated hypertension
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Cardiac disorders
unstable angina
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
acute bronchitis requiring hospitalization
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Nervous system disorders
possible seizure with hospitalization
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
Other adverse events
| Measure |
Placebo
n=17 participants at risk
Placebo
Placebo: Cellulose Placebo Capsule
|
Doxycycline Monohydrate
n=16 participants at risk
doxycycline monohydrate: 50 mg
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
bursitis left knee
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Infections and infestations
cellulitis left leg
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Nervous system disorders
Charcot right foot and ankle
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.9%
1/17 • 24 months
|
18.8%
3/16 • 24 months
|
|
Eye disorders
cloudy left eye
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
chest cold
|
11.8%
2/17 • 24 months
|
25.0%
4/16 • 24 months
|
|
Gastrointestinal disorders
intestinal flu
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
5.9%
1/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Eye disorders
macular edema
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
General disorders
dehydration
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Psychiatric disorders
depression
|
11.8%
2/17 • 24 months
|
12.5%
2/16 • 24 months
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Gastrointestinal disorders
diarrhea
|
5.9%
1/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Eye disorders
diplopia
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Eye disorders
dry eyes
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Metabolism and nutrition disorders
episodal gout
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Renal and urinary disorders
fluid retention
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Infections and infestations
gum infection
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
herniated nucleus pulposus
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Metabolism and nutrition disorders
high calcium
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Immune system disorders
hives
|
11.8%
2/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Cardiac disorders
hypertension
|
5.9%
1/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Skin and subcutaneous tissue disorders
ingrown hair left forearm
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Renal and urinary disorders
kidney stone
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Blood and lymphatic system disorders
systemic capillary leak syndrome
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Infections and infestations
MRSA
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
muscle aches
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
muscle spasms over heart
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Gastrointestinal disorders
nausea
|
5.9%
1/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Eye disorders
ocular migraine
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Eye disorders
posterior capsule opacification
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Nervous system disorders
peripheral neuropathy
|
11.8%
2/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
possible broken left thumb
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Nervous system disorders
probable seizure
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Eye disorders
right eye corneal abrasion
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
right foot plantar fascitis
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
right heel pain
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
right knee pain
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
right rotator cuff tear
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Immune system disorders
seasonal allergies
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
sinus infection
|
11.8%
2/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
sleep apnea
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
General disorders
sleep trouble
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
stenosis tenosynovitis
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
strain to left knee ligaments and tendons
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
tendonitis
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
trouble breathing
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Renal and urinary disorders
urinary tract infection
|
5.9%
1/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Infections and infestations
right foot infection
|
11.8%
2/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Eye disorders
glaucoma
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
4 broken toes left foot
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Gastrointestinal disorders
acid reflux
|
11.8%
2/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
arm weakness and numbness
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
0.00%
0/17 • 24 months
|
12.5%
2/16 • 24 months
|
|
Surgical and medical procedures
bilateral excision of ingrown toenails of big toes
|
0.00%
0/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Gastrointestinal disorders
bloating
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Renal and urinary disorders
blood in urine / kidney stone
|
5.9%
1/17 • 24 months
|
0.00%
0/16 • 24 months
|
|
Eye disorders
blurry vision
|
11.8%
2/17 • 24 months
|
6.2%
1/16 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
5.9%
1/17 • 24 months
|
6.2%
1/16 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place