Trial Outcomes & Findings for Alpha Lipoic Acid in Geographic Atrophy (NCT NCT02613572)
NCT ID: NCT02613572
Last Updated: 2020-08-06
Results Overview
The percent of adverse events that develop will be stratified by the alpha lipoic acid dose.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
68 participants
Primary outcome timeframe
15 days
Results posted on
2020-08-06
Participant Flow
Phase I: 15 subjects took escalating ALA doses (600mg, 800mg, 1200mg). 1 subject withdrew after 800mg due to wanting to delay start of 1200mg dose beyond planned completion date. Phase II: 52 subjects randomized to placebo or 1200mg ALA. 1 subject died due to unrelated event and was replaced in study; thus, 53 total subjects were enrolled.
Participant milestones
| Measure |
Alpha Lipoic Acid (ALA) 600, 800, 1200 mg
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Placebo 1200mg
Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
|
Alpha Lipoic Acid (ALA) 1200mg
Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
|
|---|---|---|---|
|
Phase I: Tolerability, 600, 800, 1200 mg
STARTED
|
15
|
0
|
0
|
|
Phase I: Tolerability, 600, 800, 1200 mg
600 mg
|
15
|
0
|
0
|
|
Phase I: Tolerability, 600, 800, 1200 mg
800 mg
|
15
|
0
|
0
|
|
Phase I: Tolerability, 600, 800, 1200 mg
1200 mg
|
14
|
0
|
0
|
|
Phase I: Tolerability, 600, 800, 1200 mg
COMPLETED
|
14
|
0
|
0
|
|
Phase I: Tolerability, 600, 800, 1200 mg
NOT COMPLETED
|
1
|
0
|
0
|
|
Phase II: Double-Blind Rand Plac Control
STARTED
|
0
|
27
|
26
|
|
Phase II: Double-Blind Rand Plac Control
COMPLETED
|
0
|
26
|
26
|
|
Phase II: Double-Blind Rand Plac Control
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Alpha Lipoic Acid (ALA) 600, 800, 1200 mg
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Placebo 1200mg
Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
|
Alpha Lipoic Acid (ALA) 1200mg
Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
|
|---|---|---|---|
|
Phase I: Tolerability, 600, 800, 1200 mg
Physician Decision
|
1
|
0
|
0
|
|
Phase II: Double-Blind Rand Plac Control
Death
|
0
|
1
|
0
|
Baseline Characteristics
Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Bilateral Geographic Atrophy, which is why no patients are included in the count of participants for this baseline measure.
Baseline characteristics by cohort
| Measure |
Alpha Lipoic Acid (ALA) 600, 800 &1200 mg
n=15 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Placebo 1200mg
n=27 Participants
Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
|
Alpha Lipoic Acid (ALA) 1200mg
n=26 Participants
Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.7 years
STANDARD_DEVIATION 3.3 • n=15 Participants
|
79.0 years
STANDARD_DEVIATION 7.0 • n=27 Participants
|
80.6 years
STANDARD_DEVIATION 6.5 • n=26 Participants
|
77.8 years
STANDARD_DEVIATION 7.2 • n=68 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=15 Participants
|
16 Participants
n=27 Participants
|
18 Participants
n=26 Participants
|
44 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=15 Participants
|
11 Participants
n=27 Participants
|
8 Participants
n=26 Participants
|
24 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=15 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
3 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=15 Participants
|
26 Participants
n=27 Participants
|
24 Participants
n=26 Participants
|
62 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
3 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
27 participants
n=27 Participants
|
26 participants
n=26 Participants
|
68 participants
n=68 Participants
|
|
Bilateral Geographic Atrophy
Yes
|
0 Participants
Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Bilateral Geographic Atrophy, which is why no patients are included in the count of participants for this baseline measure.
|
24 Participants
n=27 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Bilateral Geographic Atrophy, which is why no patients are included in the count of participants for this baseline measure.
|
23 Participants
n=26 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Bilateral Geographic Atrophy, which is why no patients are included in the count of participants for this baseline measure.
|
47 Participants
n=53 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Bilateral Geographic Atrophy, which is why no patients are included in the count of participants for this baseline measure.
|
|
Bilateral Geographic Atrophy
No
|
0 Participants
Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Bilateral Geographic Atrophy, which is why no patients are included in the count of participants for this baseline measure.
|
3 Participants
n=27 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Bilateral Geographic Atrophy, which is why no patients are included in the count of participants for this baseline measure.
|
3 Participants
n=26 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Bilateral Geographic Atrophy, which is why no patients are included in the count of participants for this baseline measure.
|
6 Participants
n=53 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Bilateral Geographic Atrophy, which is why no patients are included in the count of participants for this baseline measure.
|
|
Geographic Atrophy Lipoic Acid Study (GALA) Eligible Eyes
Unilateral
|
0 Participants
Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Geographic Atrophy Lipoic Acid Study (GALA) Eligible Eyes, which is why no patients are included in the count of participants for this baseline measure.
|
17 Participants
n=27 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Geographic Atrophy Lipoic Acid Study (GALA) Eligible Eyes, which is why no patients are included in the count of participants for this baseline measure.
|
16 Participants
n=26 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Geographic Atrophy Lipoic Acid Study (GALA) Eligible Eyes, which is why no patients are included in the count of participants for this baseline measure.
|
33 Participants
n=53 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Geographic Atrophy Lipoic Acid Study (GALA) Eligible Eyes, which is why no patients are included in the count of participants for this baseline measure.
|
|
Geographic Atrophy Lipoic Acid Study (GALA) Eligible Eyes
Bilateral
|
0 Participants
Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Geographic Atrophy Lipoic Acid Study (GALA) Eligible Eyes, which is why no patients are included in the count of participants for this baseline measure.
|
10 Participants
n=27 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Geographic Atrophy Lipoic Acid Study (GALA) Eligible Eyes, which is why no patients are included in the count of participants for this baseline measure.
|
10 Participants
n=26 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Geographic Atrophy Lipoic Acid Study (GALA) Eligible Eyes, which is why no patients are included in the count of participants for this baseline measure.
|
20 Participants
n=53 Participants • Phase I (Alpha Lipoic Acid (ALA) 600, 800 \&1200 mg) subjects did not have their eyes measured for Geographic Atrophy Lipoic Acid Study (GALA) Eligible Eyes, which is why no patients are included in the count of participants for this baseline measure.
|
PRIMARY outcome
Timeframe: 15 daysPopulation: Phase I: 15 subjects took escalating ALA doses (600mg, 800mg, 1200mg). 1 subject withdrew after 800mg due to wanting to delay start of 1200mg dose beyond planned completion date.
The percent of adverse events that develop will be stratified by the alpha lipoic acid dose.
Outcome measures
| Measure |
Alpha Lipoic Acid (ALA) 600 mg
n=15 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 800 mg
n=15 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 1200 mg
n=14 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
|---|---|---|---|
|
Phase I: Percentage of Participants With Adverse Events
|
11 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Phase II: 52 subjects randomized to placebo or 1200mg ALA. 1 subject died due to unrelated event and was replaced in study; thus, 53 total subjects were enrolled, but 52 subjects were analyzed in this outcome.
The rate of change over time in area of Geographic Atrophy (GA) in the study eye. This is determined by masked grading of Fundus Autofluorescence by an image reading center, in participants randomized to placebo or 1200 mg once daily of ALA. The values represent the annualized change from baseline to 18 months. Mean annual geographic atrophy growth rate was calculated by taking the total atrophy area at 18 months minus the baseline area. This value was then divided by 18 months and then multiplied by 12 months to get the annual growth rate. Timepoints for the study were baseline, 0, 6, 12, and 18 months. The baseline and 18 month timepoints were used for the annualized calculations as noted below.
Outcome measures
| Measure |
Alpha Lipoic Acid (ALA) 600 mg
n=26 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 800 mg
n=26 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 1200 mg
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
|---|---|---|---|
|
Phase II: Mean Annual Growth of Geographic Atrophy (Fundus Autofluorescence) - Total Area of Geographic Atrophy (mm2) - Unadjusted
|
1.21 mm^2/year
Standard Deviation 0.13
|
1.71 mm^2/year
Standard Deviation 0.13
|
—
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Phase II: 52 subjects randomized to placebo or 1200mg ALA. 1 subject died due to unrelated event and was replaced in study; thus, 53 total subjects were enrolled, but 52 subjects were analyzed in this outcome.
The rate of change over time in area of Geographic Atrophy (GA) in the study eye. This is determined by masked grading of Fundus Autofluorescence by an image reading center, in participants randomized to placebo or 1200 mg once daily of ALA. The values represent the annualized change from baseline to 18 months. Mean annual geographic atrophy growth rate was calculated by taking the total atrophy area at 18 months minus the baseline area. This value was then divided by 18 months and then multiplied by 12 months to get the annual growth rate. Timepoints for the study were baseline, 0, 6, 12, and 18 months. The baseline and 18 month timepoints were used for the annualized calculations as noted below.
Outcome measures
| Measure |
Alpha Lipoic Acid (ALA) 600 mg
n=26 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 800 mg
n=26 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 1200 mg
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
|---|---|---|---|
|
Phase II: Mean Annual Growth of Geographic Atrophy (Fundus Autofluorescence) - Total Area of GA (mm2) - Adjusted
|
1.29 mm^2/year
Standard Deviation 0.23
|
1.63 mm^2/year
Standard Deviation 0.28
|
—
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Phase II: 52 subjects randomized to placebo or 1200mg ALA. 1 subject died due to unrelated event and was replaced in study; thus, 53 total subjects were enrolled, but 52 subjects were analyzed in this outcome.
The rate of change over time in area of Geographic Atrophy (GA) in the study eye. This is determined by masked grading of Fundus Autofluorescence (FAF) by an image reading center, in participants randomized to placebo or 1200 mg once daily of ALA. The values represent the annualized change from baseline to 18 months. Mean annual geographic atrophy growth rate was calculated by taking the total atrophy area at 18 months minus the baseline area. This value was then divided by 18 months and then multiplied by 12 months to get the annual growth rate. For square root transformed data, the square root of area was used. Timepoints for the study were baseline, 0, 6, 12, and 18 months. The baseline and 18 month timepoints were used for the annualized calculations as noted below.
Outcome measures
| Measure |
Alpha Lipoic Acid (ALA) 600 mg
n=26 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 800 mg
n=26 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 1200 mg
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
|---|---|---|---|
|
Phase II: Mean Annual Growth of Geographic Atrophy (Fundus Autofluorescence) - Square Root of Area of GA (mm) - Unadjusted
|
0.28 mm/year
Standard Deviation 0.02
|
0.31 mm/year
Standard Deviation 0.02
|
—
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Phase II: 52 subjects randomized to placebo or 1200mg ALA. 1 subject died due to unrelated event and was replaced in study; thus, 53 total subjects were enrolled, but 52 subjects were analyzed in this outcome.
The rate of change over time in area of Geographic Atrophy (GA) in the study eye. This is determined by masked grading of Fundus Autofluorescence (FAF) by an image reading center, in participants randomized to placebo or 1200 mg once daily of ALA. The values represent the annualized change from baseline to 18 months. Mean annual geographic atrophy growth rate was calculated by taking the total atrophy area at 18 months minus the baseline area. This value was then divided by 18 months and then multiplied by 12 months to get the annual growth rate. For square root transformed data, the square root of area was used. Timepoints for the study were baseline, 0, 6, 12, and 18 months. The baseline and 18 month timepoints were used for the annualized calculations as noted below.
Outcome measures
| Measure |
Alpha Lipoic Acid (ALA) 600 mg
n=26 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 800 mg
n=26 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 1200 mg
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
|---|---|---|---|
|
Phase II: Mean Annual Growth of Geographic Atrophy (Fundus Autofluorescence) - Square Root of Area of GA (mm) - Adjusted
|
0.27 mm/year
Standard Deviation 0.04
|
0.32 mm/year
Standard Deviation 0.05
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Phase II: 52 subjects randomized to placebo or 1200mg ALA. 1 subject died due to unrelated event and was replaced in study; thus, 53 total subjects were enrolled, but 52 subjects were analyzed in this outcome.
Unit of Measure. Mean annual change in best-corrected visual acuity was calculated by taking the letter score at 18 months minus the baseline letter score. This value was then divided by 18 months and then multiplied by 12 months to get the mean annual change in visual acuity. Timepoints for the study were baseline, 0, 6, 12, and 18 months. The baseline and 18 month timepoints were used for the annualized calculations as noted below.
Outcome measures
| Measure |
Alpha Lipoic Acid (ALA) 600 mg
n=26 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 800 mg
n=26 Participants
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 1200 mg
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
|---|---|---|---|
|
Phase II: Mean Annual Change in Best-Corrected Visual Acuity (BCVA)
|
-3.8 letters/year
Standard Deviation 1.1
|
-3.1 letters/year
Standard Deviation 1.12
|
—
|
Adverse Events
Alpha Lipoic Acid (ALA) 600 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Alpha Lipoic Acid (ALA) 800 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Alpha Lipoic Acid (ALA) 1200 mg (Phase I)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo 1200mg
Serious events: 5 serious events
Other events: 24 other events
Deaths: 1 deaths
Alpha Lipoic Acid (ALA) 1200mg (Phase II)
Serious events: 10 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alpha Lipoic Acid (ALA) 600 mg
n=15 participants at risk
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 800 mg
n=15 participants at risk
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 1200 mg (Phase I)
n=14 participants at risk
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Placebo 1200mg
n=27 participants at risk
Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
|
Alpha Lipoic Acid (ALA) 1200mg (Phase II)
n=26 participants at risk
Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
3.7%
1/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
3.7%
1/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Vascular disorders
Thrombosis
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Injury, poisoning and procedural complications
Subarachnoid Haemorrhage
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
3.7%
1/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
Other adverse events
| Measure |
Alpha Lipoic Acid (ALA) 600 mg
n=15 participants at risk
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 800 mg
n=15 participants at risk
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Alpha Lipoic Acid (ALA) 1200 mg (Phase I)
n=14 participants at risk
Phase I: All subjects recruited to the Phase I part will take escalating doses of alpha lipoic acid (ALA) open label. Each enrolled subject will take 600 mg of oral ALA once daily with a meal for 5 days. If well-tolerated, each subject will then take 800 mg of oral ALA once daily with a meal for 5 additional days. If 800 mg of oral ALA is well-tolerated, then subjects will then take 1200 mg of oral ALA once daily with a meal for 5 days.
|
Placebo 1200mg
n=27 participants at risk
Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
|
Alpha Lipoic Acid (ALA) 1200mg (Phase II)
n=26 participants at risk
Phase II: All subjects in Phase II will be double blinded and randomized to either placebo or ALA. Each will take one 600 mg capsule of ALA (or placebo) once daily with a meal for 2 weeks and then increase to two 600 mg capsules of ALA (or placebo) once daily with a meal for the entire remainder of the 18 month period of the study.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Acid Reflux (Dyspepsia)
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
7.1%
1/14 • Phase I: 15 Days; Phase II: 18 Months
|
3.7%
1/27 • Phase I: 15 Days; Phase II: 18 Months
|
23.1%
6/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Phase I: 15 Days; Phase II: 18 Months
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
7.1%
1/14 • Phase I: 15 Days; Phase II: 18 Months
|
22.2%
6/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Gastrointestinal disorders
Loose Stools
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
20.0%
3/15 • Phase I: 15 Days; Phase II: 18 Months
|
7.1%
1/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
7.1%
1/14 • Phase I: 15 Days; Phase II: 18 Months
|
3.7%
1/27 • Phase I: 15 Days; Phase II: 18 Months
|
26.9%
7/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
7.1%
1/14 • Phase I: 15 Days; Phase II: 18 Months
|
3.7%
1/27 • Phase I: 15 Days; Phase II: 18 Months
|
19.2%
5/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
General disorders
Fatigue
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
General disorders
Weakness (Asthenia)
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Musculoskeletal and connective tissue disorders
Leg (Muscle) Cramps
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
7.1%
1/14 • Phase I: 15 Days; Phase II: 18 Months
|
11.1%
3/27 • Phase I: 15 Days; Phase II: 18 Months
|
15.4%
4/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
7.1%
1/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Renal and urinary disorders
Abnormal Urine Odor
|
53.3%
8/15 • Phase I: 15 Days; Phase II: 18 Months
|
46.7%
7/15 • Phase I: 15 Days; Phase II: 18 Months
|
50.0%
7/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
11.5%
3/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
7.1%
1/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Renal and urinary disorders
Increased Urinary Frequency
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Renal and urinary disorders
Urinary Urgency
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
7.1%
1/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Vascular disorders
Flushing
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
7.1%
1/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Vascular disorders
Hot Flashes
|
6.7%
1/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
7.1%
1/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Eye disorders
Angle Closure Glaucoma
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Eye disorders
Blepharitis
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Eye disorders
Blindness
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
11.5%
3/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Eye disorders
Cataract
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
11.1%
3/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Eye disorders
Retinal Haemorrhage
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Eye disorders
Vision Blurred
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
14.8%
4/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
22.2%
6/27 • Phase I: 15 Days; Phase II: 18 Months
|
26.9%
7/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Eye disorders
Visual Disturbance
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
11.1%
3/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
3.7%
1/27 • Phase I: 15 Days; Phase II: 18 Months
|
11.5%
3/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
3.7%
1/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Gastrointestinal disorders
Giardiasis
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
23.1%
6/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
General disorders
Influenza Like Illness
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
14.8%
4/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
14.8%
4/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
11.1%
3/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
22.2%
6/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
19.2%
5/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Injury, poisoning and procedural complications
Back Injury
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
11.5%
3/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Investigations
Weight Decreased
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
3.7%
1/27 • Phase I: 15 Days; Phase II: 18 Months
|
19.2%
5/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
3.7%
1/27 • Phase I: 15 Days; Phase II: 18 Months
|
15.4%
4/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Nervous system disorders
Ageusia
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
3.8%
1/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
3.7%
1/27 • Phase I: 15 Days; Phase II: 18 Months
|
11.5%
3/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Renal and urinary disorders
Hypertonic Bladder
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
7.7%
2/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/27 • Phase I: 15 Days; Phase II: 18 Months
|
11.5%
3/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Skin and subcutaneous tissue disorders
Precancerous Skin Lesion
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
7.4%
2/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/15 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/14 • Phase I: 15 Days; Phase II: 18 Months
|
11.1%
3/27 • Phase I: 15 Days; Phase II: 18 Months
|
0.00%
0/26 • Phase I: 15 Days; Phase II: 18 Months
|
Additional Information
Benjamin J. Kim, MD
Scheie Eye Institute; Perelman School of Medicine; University of Pennsylvania
Phone: 215-662-8675
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place