Trial Outcomes & Findings for Stop Retinal Ganglion Cell Dysfunction Study (NCT NCT02390284)
NCT ID: NCT02390284
Last Updated: 2025-08-26
Results Overview
As measured by Optical Coherence Tomography in different timepoints as an absolute value in micrometers.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
28 participants
Primary outcome timeframe
Baseline
Results posted on
2025-08-26
Participant Flow
No patients had abnormal PERG and could not be included in the first two arms from the baseline timepoint. This significantly altered the study since the patients could not be randomized, and the treatment of each patient was determined by the physician's discretion.
Participant milestones
| Measure |
Abnormal PERG Untreated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to not receive therapy or intervention.
|
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
Latanoprost: Lower intraocular pressure (IOP) by increasing outflow of fluid from the eye.
Bimatoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Travoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Timolol: Lower intraocular pressure by decreasing production of fluid
Dorzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Brinzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Acetazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Methazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
|
Normal
Patients with a normal PERG test that will go through the study under observation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
28
|
|
Overall Study
COMPLETED
|
0
|
0
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
9
|
Reasons for withdrawal
| Measure |
Abnormal PERG Untreated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to not receive therapy or intervention.
|
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
Latanoprost: Lower intraocular pressure (IOP) by increasing outflow of fluid from the eye.
Bimatoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Travoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Timolol: Lower intraocular pressure by decreasing production of fluid
Dorzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Brinzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Acetazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Methazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
|
Normal
Patients with a normal PERG test that will go through the study under observation.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
9
|
Baseline Characteristics
Stop Retinal Ganglion Cell Dysfunction Study
Baseline characteristics by cohort
| Measure |
Abnormal PERG Untreated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to not receive therapy or intervention.
|
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
Latanoprost: Lower intraocular pressure (IOP) by increasing outflow of fluid from the eye.
Bimatoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Travoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Timolol: Lower intraocular pressure by decreasing production of fluid
Dorzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Brinzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Acetazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Methazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
|
Normal
n=28 Participants
Patients with a normal PERG test that will go through the study under observation.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Continuous
|
—
|
—
|
62.03 years
n=5 Participants
|
62.03 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
28 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
PERG Amplitude
|
—
|
—
|
787.785714 nanovolts
n=5 Participants
|
787.785714 nanovolts
n=4 Participants
|
|
PERG Phase
|
—
|
—
|
66.92857 degrees
n=5 Participants
|
66.92857 degrees
n=4 Participants
|
|
IOP
|
—
|
—
|
18 mmHg
n=5 Participants
|
18 mmHg
n=4 Participants
|
|
OCT-RNFL thickness
|
—
|
—
|
85 micrometers
n=5 Participants
|
85 micrometers
n=4 Participants
|
|
Visual Field
|
—
|
—
|
28 participants
n=5 Participants
|
28 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: No patients had abnormal PERG and could not be included in the first two arms from the baseline timepoint, only baseline measurements could be included.
As measured by Optical Coherence Tomography in different timepoints as an absolute value in micrometers.
Outcome measures
| Measure |
Abnormal PERG Untreated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to not receive therapy or intervention.
|
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
Latanoprost: Lower intraocular pressure (IOP) by increasing outflow of fluid from the eye.
Bimatoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Travoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Timolol: Lower intraocular pressure by decreasing production of fluid
Dorzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Brinzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Acetazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Methazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
|
Normal
n=28 Participants
Patients with a normal PERG test that will go through the study under observation.
|
|---|---|---|---|
|
Retinal Nerve Fiber Layer Thickness
|
—
|
—
|
79 micrometers
Interval 76.0 to 89.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: No patients had abnormal PERG and could not be included in the first two arms from the baseline timepoint, only baseline measurements could be included.
Assessed via Pattern Electroretinogram in nanovolts
Outcome measures
| Measure |
Abnormal PERG Untreated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to not receive therapy or intervention.
|
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
Latanoprost: Lower intraocular pressure (IOP) by increasing outflow of fluid from the eye.
Bimatoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Travoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Timolol: Lower intraocular pressure by decreasing production of fluid
Dorzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Brinzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Acetazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Methazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
|
Normal
n=28 Participants
Patients with a normal PERG test that will go through the study under observation.
|
|---|---|---|---|
|
Pattern Electroretinogram Amplitude
|
—
|
—
|
706 nanovolts
Interval 455.0 to 1344.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: No patients had abnormal PERG and could not be included in the first two arms from the baseline timepoint, only baseline measurements could be included.
Assessed via Pattern Electroretinogram in degrees
Outcome measures
| Measure |
Abnormal PERG Untreated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to not receive therapy or intervention.
|
Abnormal PERG Treated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%.
Drugs could be:
Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation.
If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.
Latanoprost: Lower intraocular pressure (IOP) by increasing outflow of fluid from the eye.
Bimatoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Travoprost: Lower intraocular pressure by increasing outflow of fluid from the eye.
Timolol: Lower intraocular pressure by decreasing production of fluid
Dorzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Brinzolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Acetazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
Methazolamide: Lowers intraocular pressure by decreasing intraocular fluid production
|
Normal
n=28 Participants
Patients with a normal PERG test that will go through the study under observation.
|
|---|---|---|---|
|
Pattern Electroretinogram Phase
|
—
|
—
|
67.34 degrees
Interval 22.0 to 96.0
|
Adverse Events
Abnormal PERG Untreated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Abnormal PERG Treated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place