Trial Outcomes & Findings for Minocycline to Treat Branch Retinal Vein Occlusion (NCT NCT01468831)
NCT ID: NCT01468831
Last Updated: 2022-01-26
Results Overview
The primary outcome measure is the mean difference between the minocycline and placebo groups in the change in best-corrected visual acuity (BCVA), as measured in ETDRS letters, in the study eye at 12 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 12 months.
COMPLETED
PHASE1/PHASE2
9 participants
Baseline to Month 12
2022-01-26
Participant Flow
Recriutment was activated on November 18, 2011 at the NEI site and on May 25, 2018 at the BEH site. Enrollment was closed on May 13, 2019 at the NEI site and on December 31, 2019 at the BEH site.
Unit of analysis: Eye
Participant milestones
| Measure |
Placebo
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
Minocycline
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
|---|---|---|
|
Overall Study
STARTED
|
4 4
|
5 5
|
|
Overall Study
Month 12 (Primary Outcome)
|
4 4
|
4 4
|
|
Overall Study
COMPLETED
|
4 4
|
4 4
|
|
Overall Study
NOT COMPLETED
|
0 0
|
1 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Minocycline to Treat Branch Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
Minocycline
n=5 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 11.21 • n=93 Participants
|
70.6 years
STANDARD_DEVIATION 5.55 • n=4 Participants
|
67.0 years
STANDARD_DEVIATION 8.99 • n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
4 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: The primary outcome analysis population includes those participants who were exposed to IP and were followed up for at least 12 months. One participant in the minocycline group was excluded from the analysis because their Month 12 data was not recorded due to their withdrawal from the study prior to Month 12.
The primary outcome measure is the mean difference between the minocycline and placebo groups in the change in best-corrected visual acuity (BCVA), as measured in ETDRS letters, in the study eye at 12 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 12 months.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Mean Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline.
|
13.0 ETDRS letters
Standard Deviation 11.3
|
5.3 ETDRS letters
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol.
The outcome measure is the difference between the minocycline and placebo groups in the number of bevacizumab injections administered to participants between baseline and 12 months.
Outcome measures
| Measure |
Minocycline
n=5 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Number of Bevacizumab Injections From Baseline to 12 Months
|
6.6 bevacizumab injections
Standard Deviation 2.4
|
5.5 bevacizumab injections
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol.
The outcome measure is the difference between the minocycline and placebo groups in the number of bevacizumab injections administered to participants between baseline and 24 months.
Outcome measures
| Measure |
Minocycline
n=5 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Number of Bevacizumab Injections From Baseline to 24 Months
|
8.8 bevacizumab injections
Standard Deviation 4.2
|
9.0 bevacizumab injections
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline to Month 3Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol.
The outcome measure is the mean difference between the minocycline and placebo groups in the change in macular sensitivity as measured by microperimetry in the study eye at 3 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 3 months. Higher macular sensitivity (higher db) is better.
Outcome measures
| Measure |
Minocycline
n=5 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 3 Months Compared to Baseline
|
-0.4 db
Standard Deviation 2.5
|
0.5 db
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol.
The outcome measure is the mean difference between the minocycline and placebo groups in the change in macular sensitivity as measured by microperimetry in the study eye at 6 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 6 months. Higher macular sensitivity (higher db) is better.
Outcome measures
| Measure |
Minocycline
n=5 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 6 Months Compared to Baseline
|
-1.5 db
Standard Deviation 1.7
|
0.7 db
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded because their Month 12 data was not recorded due to withdrawal from the study prior to the Month 12 visit.
The outcome measure is the mean difference between the minocycline and placebo groups in the change in macular sensitivity as measured by microperimetry in the study eye at 12 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 12 months. Higher macular sensitivity (higher db) is better.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 12 Months Compared to Baseline
|
-1.4 db
Standard Deviation 3.3
|
1.1 db
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. Two participants in the minocycline group was excluded due to missing macular sensitivity data at Month 18.
The outcome measure is the mean difference between the minocycline and placebo groups in the change in macular sensitivity as measured by microperimetry in the study eye at 18 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 18 months. Higher macular sensitivity (higher db) is better.
Outcome measures
| Measure |
Minocycline
n=3 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 18 Months Compared to Baseline
|
-3.1 db
Standard Deviation 2.9
|
0.4 db
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded because their Month 24 data was not recorded due to withdrawal from the study prior to the Month 24 visit.
The outcome measure is the mean difference between the minocycline and placebo groups in the change in macular sensitivity as measured by microperimetry in the study eye at 24 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 24 months. Higher macular sensitivity (higher db) is better.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 24 Months Compared to Baseline
|
-3.7 db
Standard Deviation 3.5
|
0.1 db
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded because their Month 24 data was not recorded due to withdrawal from the study prior to the Month 24 visit.
The outcome measure is the mean difference between the minocycline and placebo groups in the change in best-corrected visual acuity (BCVA), as measured in ETDRS letters, in the study eye at 24 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 24 months.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Mean Change in the ETDRS BCVA in the Study Eye at 24 Months Compared to Baseline
|
8.5 ETDRS letters
Standard Deviation 14.8
|
2.8 ETDRS letters
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol.
The outcome measure is the mean difference between the minocycline and placebo groups in the change in central retinal thickness in the study eye at 6 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 6 months.
Outcome measures
| Measure |
Minocycline
n=5 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 6 Months Compared to Baseline
|
-142.8 micrometers
Standard Deviation 146.5
|
-91.0 micrometers
Standard Deviation 53.8
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded because their Month 12 data was not recorded due to withdrawal from the study prior to the Month 12 visit.
The outcome measure is the mean difference between the minocycline and placebo groups in the change in central retinal thickness in the study eye at 12 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 12 months.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 12 Months Compared to Baseline
|
-144.8 micrometers
Standard Deviation 303.7
|
-99.3 micrometers
Standard Deviation 45.0
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded because their Month 18 data was not recorded due to withdrawal from the study prior to the Month 18 visit.
The outcome measure is the mean difference between the minocycline and placebo groups in the change in central retinal thickness in the study eye at 18 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 18 months.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 18 Months Compared to Baseline
|
-124.5 micrometers
Standard Deviation 321.3
|
-111.8 micrometers
Standard Deviation 63.9
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded because their Month 24 data was not recorded due to withdrawal from the study prior to the Month 24 visit.
The outcome measure is the mean difference between the minocycline and placebo groups in the change in central retinal thickness in the study eye at 24 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 24 months.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 24 Months Compared to Baseline
|
-135.3 micrometers
Standard Deviation 307.0
|
-125.8 micrometers
Standard Deviation 63.4
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded because their Month 12 data was not recorded due to withdrawal from the study prior to the Month 12 visit.
The outcome measure is the difference between the minocycline and placebo groups in the number of participants experiencing an improvement of ≥ 1 logOCT scale step from baseline to Month 12. Improvement in ≥ 1 logOCT scale step is defined as a decrease of ≥ 1-step on the logOCT scale. A 1-step decrease is equivalent to at least a 20% improvement of central macular thickness.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Number of Participants Improving ≥ 1 logOCT Scale Step in the Study Eye at 12 Months Compared to Baseline
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded because their Month 24 data was not recorded due to withdrawal from the study prior to the Month 24 visit.
The outcome measure is the difference between the minocycline and placebo groups in the number of participants experiencing an improvement of ≥ 1 logOCT scale step from baseline to Month 24. Improvement in ≥ 1 logOCT scale step is defined as a decrease of ≥ 1-step on the logOCT scale. A 1-step decrease is equivalent to at least a 20% improvement of central macular thickness.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Number of Participants Improving ≥ 1 logOCT Scale Step in the Study Eye at 24 Months Compared to Baseline
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded because their Month 12 data was not recorded due to withdrawal from the study prior to the Month 12 visit.
The outcome measure is the difference between the between the minocycline and placebo groups in the number of participants experiencing changes in fluid leakage in the macula of the study eye as demonstrated by fluorescein angiography at 12 months compared to baseline. The counts presented are the number of participants experiencing decrease, increase, or no change in fluid leakage from baseline.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Number of Participants Experiencing Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 12 Months Compared to Baseline
Decrease
|
2 participants
|
4 participants
|
|
Number of Participants Experiencing Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 12 Months Compared to Baseline
Increase
|
0 participants
|
0 participants
|
|
Number of Participants Experiencing Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 12 Months Compared to Baseline
No Change
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: The secondary outcomes are based on the safety population, which includes all participants who were exposed to IP, regardless of adherence to protocol. One participant in the minocycline group was excluded because their Month 24 data was not recorded due to withdrawal from the study prior to the Month 24 visit.
The outcome measure is the difference between the between the minocycline and placebo groups in the number of participants experiencing changes in fluid leakage in the macula of the study eye as demonstrated by fluorescein angiography at 24 months compared to baseline. The counts presented are the number of participants experiencing decrease, increase, or no change in fluid leakage from baseline.
Outcome measures
| Measure |
Minocycline
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
Placebo
n=4 Participants
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
|---|---|---|
|
Number of Participants Experiencing Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 24 Months Compared to Baseline.
Decrease
|
3 participants
|
4 participants
|
|
Number of Participants Experiencing Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 24 Months Compared to Baseline.
Increase
|
1 participants
|
0 participants
|
|
Number of Participants Experiencing Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 24 Months Compared to Baseline.
No Change
|
0 participants
|
0 participants
|
Adverse Events
Placebo
Minocycline
Serious adverse events
| Measure |
Placebo
n=4 participants at risk
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
Minocycline
n=5 participants at risk
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
|---|---|---|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Placebo
n=4 participants at risk
Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
Placebo: Pill with inactive ingredients in a pink opaque capsule
|
Minocycline
n=5 participants at risk
Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months
Minocycline: 100 mg of minocycline in a pink opaque capsule
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 4 • 24 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • 24 months
|
40.0%
2/5 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 2 • 24 months
|
0.00%
0/5 • 24 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Oral mucosal discolouration
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
2/4 • Number of events 4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Infections and infestations
Laryngitis
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/5 • 24 months
|
|
Infections and infestations
Mastitis
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • 24 months
|
40.0%
2/5 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 2 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Nervous system disorders
Dizziness postural
|
25.0%
1/4 • Number of events 1 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/5 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
25.0%
1/4 • Number of events 1 • 24 months
|
20.0%
1/5 • Number of events 3 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Eye disorders
Conjunctival haemorrhage
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/5 • 24 months
|
|
Eye disorders
Ocular discomfort
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/5 • 24 months
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Eye disorders
Vitreous floaters
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/5 • 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Investigations
Blood glucose increased
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Investigations
Renal function test abnormal
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/5 • 24 months
|
|
Investigations
Thyroid function test abnormal
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • 24 months
|
40.0%
2/5 • Number of events 2 • 24 months
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/5 • 24 months
|
|
General disorders
Adverse drug reaction
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
25.0%
1/4 • Number of events 1 • 24 months
|
0.00%
0/5 • 24 months
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Eye disorders
Retinal pigmentation
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 1 • 24 months
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/4 • 24 months
|
20.0%
1/5 • Number of events 2 • 24 months
|
Additional Information
Catherine Cukras, MD, PhD, Principal Investigator, NEI
National Institutes of Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place