Trial Outcomes & Findings for Sirolimus for Advanced Age-Related Macular Degeneration (NCT NCT01445548)

NCT ID: NCT01445548

Last Updated: 2021-07-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Baseline and Month 12
• Results posted on: 2021-07-07

Participant Flow

Participant milestones

Measure	Sirolimus Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Sirolimus Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Overall Study Adverse Event	1

Baseline Characteristics

Sirolimus for Advanced Age-Related Macular Degeneration

Baseline characteristics by cohort

Measure	Sirolimus n=6 Participants Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Age, Continuous	74.33 years STANDARD_DEVIATION 8.45 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.	0.19 mm^2/month Standard Deviation 0.08

PRIMARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.	0.13 mm^2/month Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. One eye (the study eye) was initially randomized to receive intravitreal sirolimus and the fellow eye was observed as the control.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline	-15.6 ETDRS letters Standard Deviation 7.23

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. One eye (the study eye) was initially randomized to receive intravitreal sirolimus and the fellow eye was observed as the control.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 12 Months Compared to Baseline	0 ETDRS letters Standard Deviation 13.47

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.	2.26 mm^2 Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.	1.53 mm^2 Standard Deviation 0.75

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value.

Outcome measures

Measure	Sirolimus n=5 Participants Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.	0.18 Ratio Standard Deviation 0.09

SECONDARY outcome

Timeframe: Baseline and Month 12

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value.

Outcome measures

Measure	Sirolimus n=5 Participants Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.	0.14 Ratio Standard Deviation 0.09

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 3 had drusen area graded at 12 months.

The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.

Outcome measures

Measure	Sirolimus n=3 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.	0.02 MPS DA Standard Deviation 0.19

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 3 had drusen area graded at 12 months.

The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina.

Outcome measures

Measure	Sirolimus n=3 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.	0.29 MPS DA Standard Deviation 0.78

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.	2.75 mm^2 Standard Deviation 1.83

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.	1.44 mm^2 Standard Deviation 1.17

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.	2.4 mm^2 Standard Deviation 0.82

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss.The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.	1.6 mm^2 Standard Deviation 0.76

SECONDARY outcome

Timeframe: Baseline and Month 12

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.	0.21 Ratio Standard Deviation 0.14

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.	0.15 Ratio Standard Deviation 0.10

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.	0.21 Ratio Standard Deviation 0.12

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.

Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).

This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value.

Outcome measures

Measure	Sirolimus n=5 Eyes Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.	0.13 Ratio Standard Deviation 0.10

SECONDARY outcome

Timeframe: Baseline and 12 Months

Population: Zero participants were analyzed because no data were collected to analyze this outcome as no study or fellow eye developed neovascular changes during the study.

Outcome measures

Outcome data not reported

Adverse Events

Sirolimus

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sirolimus n=6 participants at risk Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Hepatobiliary disorders Hepatic cirrhosis	16.7% 1/6 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Hip fracture	16.7% 1/6 • Number of events 1 • 12 months
Cardiac disorders Heart valve incompetence	16.7% 1/6 • Number of events 1 • 12 months

Other adverse events

Measure	Sirolimus n=6 participants at risk Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated. As of September 2012, sirolimus intravitreal injections were no longer administered to participants.
Eye disorders Age-related macular degeneration	33.3% 2/6 • Number of events 2 • 12 months
Investigations Alanine aminotransferase increased	33.3% 2/6 • Number of events 2 • 12 months
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Number of events 1 • 12 months
Investigations Aspartate aminotransferase increased	16.7% 1/6 • Number of events 1 • 12 months
Investigations Basophil count decreased	16.7% 1/6 • Number of events 1 • 12 months
Investigations Blood alkaline phosphatase decreased	16.7% 1/6 • Number of events 1 • 12 months
Investigations Blood bilirubin increased	16.7% 1/6 • Number of events 1 • 12 months
Investigations Blood calcium decreased	16.7% 1/6 • Number of events 1 • 12 months
Investigations Blood glucose abnormal	50.0% 3/6 • Number of events 3 • 12 months
Investigations Blood urea increased	33.3% 2/6 • Number of events 2 • 12 months
Investigations Bone density abnormal	16.7% 1/6 • Number of events 1 • 12 months
Investigations Full blood count abnormal	16.7% 1/6 • Number of events 1 • 12 months
Investigations Haematocrit decreased	16.7% 1/6 • Number of events 1 • 12 months
Investigations Haemoglobin urine present	16.7% 1/6 • Number of events 1 • 12 months
Metabolism and nutrition disorders Hyperlipidaemia	16.7% 1/6 • Number of events 1 • 12 months
Vascular disorders Hypertension	33.3% 2/6 • Number of events 2 • 12 months
Metabolism and nutrition disorders Hypertriglyceridaemia	16.7% 1/6 • Number of events 1 • 12 months
Vascular disorders Hypotension	16.7% 1/6 • Number of events 1 • 12 months
Blood and lymphatic system disorders Leukopenia	16.7% 1/6 • Number of events 1 • 12 months
Investigations Lipids decreased	16.7% 1/6 • Number of events 1 • 12 months
Investigations Liver function test abnormal	16.7% 1/6 • Number of events 1 • 12 months
Nervous system disorders Memory impairment	16.7% 1/6 • Number of events 1 • 12 months
Investigations Monocyte count abnormal	16.7% 1/6 • Number of events 1 • 12 months
Investigations Monocyte count decreased	16.7% 1/6 • Number of events 1 • 12 months
Renal and urinary disorders Nephrolithiasis	16.7% 1/6 • Number of events 1 • 12 months
Investigations Neutrophil count decreased	16.7% 1/6 • Number of events 1 • 12 months
Eye disorders Ocular discomfort	16.7% 1/6 • Number of events 1 • 12 months
Investigations Platelet count decreased	16.7% 1/6 • Number of events 1 • 12 months
Hepatobiliary disorders Portal hypertension	16.7% 1/6 • Number of events 1 • 12 months
Investigations Red blood cell count increased	16.7% 1/6 • Number of events 1 • 12 months
Investigations Red blood cells urine	33.3% 2/6 • Number of events 2 • 12 months
Respiratory, thoracic and mediastinal disorders Respiratory disorder	16.7% 1/6 • Number of events 1 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	16.7% 1/6 • Number of events 1 • 12 months
Surgical and medical procedures Skin lesion excision	16.7% 1/6 • Number of events 1 • 12 months
Infections and infestations Urinary tract infection	50.0% 3/6 • Number of events 3 • 12 months
Eye disorders Visual acuity reduced	16.7% 1/6 • Number of events 1 • 12 months
Investigations Lipids increased	16.7% 1/6 • Number of events 1 • 12 months
General disorders Mild pain	16.7% 1/6 • Number of events 1 • 12 months

Additional Information

Wai T. Wong, MD, PhD

National Eye Institute

Phone: 301-496-7566

Email: wongw@nei.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place