Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

X-82 to Treat Age-related Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02348359
Recruitment Status : Terminated (Interim analysis found study had achieved primary objective)
First Posted : January 28, 2015
Results First Posted : June 27, 2018
Last Update Posted : July 25, 2018
Sponsor:
Collaborators:
SynteractHCR, Inc
International Drug Development Institute
Information provided by (Responsible Party):
Tyrogenex

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Age-Related Macular Degeneration (AMD)
Macular Degeneration
Exudative Age-related Macular Degeneration
AMD
Macular Degeneration, Age-related, 10
Eye Diseases
Retinal Degeneration
Retinal Diseases
Interventions Drug: X-82
Drug: Anti-VEGF
Drug: Placebo
Enrollment 157
Recruitment Details This study was conducted at 39 sites in the United States. There were 36 sites that screened subjects and 3 sites that did not screen any subjects. A total of 157 subjects were randomly assigned and treated in the study.
Pre-assignment Details  
Arm/Group Title 50 mg of X-82 Plus Ivt Anti-VEGF Prn 100 mg of X-82 Plus Ivt Anti-VEGF Prn 200 mg of X-82 Plus Ivt Anti-VEGF Prn Placebo Plus Ivt Anti-VEGF Prn
Hide Arm/Group Description

Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

Anti-VEGF

Placebo

Period Title: Overall Study
Started 40 39 39 39
Completed 29 22 25 27
Not Completed 11 17 14 12
Arm/Group Title 50 mg of X-82 Plus Ivt Anti-VEGF Prn 100 mg of X-82 Plus Ivt Anti-VEGF Prn 200 mg of X-82 Plus Ivt Anti-VEGF Prn Placebo Plus Ivt Anti-VEGF Prn Total
Hide Arm/Group Description

Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

Anti-VEGF

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 40 39 39 39 157
Hide Baseline Analysis Population Description
All randomized subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 39 participants 39 participants 39 participants 157 participants
75.7  (8.23) 73.5  (8.33) 75.0  (7.63) 75.9  (7.65) 75.0  (7.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 39 participants 39 participants 157 participants
Female
22
  55.0%
16
  41.0%
18
  46.2%
23
  59.0%
79
  50.3%
Male
18
  45.0%
23
  59.0%
21
  53.8%
16
  41.0%
78
  49.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 39 participants 39 participants 157 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   2.6%
1
   2.6%
2
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
40
 100.0%
38
  97.4%
38
  97.4%
38
  97.4%
154
  98.1%
More than one race
0
   0.0%
1
   2.6%
0
   0.0%
0
   0.0%
1
   0.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 39 participants 39 participants 39 participants 157 participants
40 39 39 39 157
Best corrected visual acuity  
Mean (Standard Deviation)
Unit of measure:  Number of letters
Number Analyzed 40 participants 39 participants 39 participants 39 participants 157 participants
72.3  (9.41) 71.2  (12.17) 71.9  (13.17) 68.8  (12.43) 71.0  (11.83)
1.Primary Outcome
Title Mean Change in Visual Acuity Score From Day -1 to Week52
Hide Description The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis restricted to subjects who completed 52 weeks of treatment
Arm/Group Title 50 mg of X-82 Plus Ivt Anti-VEGF Prn 100 mg of X-82 Plus Ivt Anti-VEGF Prn 200 mg of X-82 Plus Ivt Anti-VEGF Prn Placebo Plus Ivt Anti-VEGF Prn
Hide Arm/Group Description:

Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

Anti-VEGF

Placebo

Overall Number of Participants Analyzed 23 19 17 22
Mean (Standard Deviation)
Unit of Measure: number of letters
0.2  (4.14) -0.9  (6.57) 1.7  (5.58) -0.3  (10.63)
Time Frame All adverse events were collected and reported from time of participant study entry until discharge of last participant from the study. Individual subject participation in the study ranged from 0-14 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 50 mg of X-82 Plus Ivt Anti-VEGF Prn 100 mg of X-82 Plus Ivt Anti-VEGF Prn 200 mg of X-82 Plus Ivt Anti-VEGF Prn Placebo Plus Ivt Anti-VEGF Prn
Hide Arm/Group Description

Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

X-82

Anti-VEGF

Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.

Anti-VEGF

Placebo

All-Cause Mortality
50 mg of X-82 Plus Ivt Anti-VEGF Prn 100 mg of X-82 Plus Ivt Anti-VEGF Prn 200 mg of X-82 Plus Ivt Anti-VEGF Prn Placebo Plus Ivt Anti-VEGF Prn
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)      1/39 (2.56%)      0/39 (0.00%)      0/39 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
50 mg of X-82 Plus Ivt Anti-VEGF Prn 100 mg of X-82 Plus Ivt Anti-VEGF Prn 200 mg of X-82 Plus Ivt Anti-VEGF Prn Placebo Plus Ivt Anti-VEGF Prn
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/40 (15.00%)      7/39 (17.95%)      3/39 (7.69%)      2/39 (5.13%)    
Cardiac disorders         
Myocardial infarction * 1  1/40 (2.50%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0
sudden cardiac death * 1  0/40 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0
Gastrointestinal disorders         
lower gastrointestinal hemorrhage * 1  0/40 (0.00%)  0 0/39 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0
General disorders         
Chest pain * 1  0/40 (0.00%)  0 0/39 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0
Infections and infestations         
Endopthalmitis * 1  0/40 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0
Influenza * 1  0/40 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0
Pneumonia * 1  0/40 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0 1/39 (2.56%)  1
Sepsis * 1  1/40 (2.50%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0
Urinary tract infection * 1  1/40 (2.50%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0
Injury, poisoning and procedural complications         
Hip fracture * 1  1/40 (2.50%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration * 1  0/40 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0
Hypokalemia * 1  0/40 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bladder cancer * 1  1/40 (2.50%)  1 1/39 (2.56%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0
Basal cell carcinoma * 1  1/40 (2.50%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0
Endometrial cancer * 1  1/40 (2.50%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0
B cell lymphoma * 1  0/40 (0.00%)  0 0/39 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0
Oesophageal carcinoma * 1  1/40 (2.50%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0
Squamous cell carcinoma * 1  1/40 (2.50%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0
Nervous system disorders         
Cerebral infarction * 1  1/40 (2.50%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0
Syncope * 1  0/40 (0.00%)  0 0/39 (0.00%)  0 0/39 (0.00%)  0 1/39 (2.56%)  1
Skin and subcutaneous tissue disorders         
Angioedema * 1  0/40 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0
Vascular disorders         
Deep vein thrombosis * 1  0/40 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0 0/39 (0.00%)  0
Hypertensive crisis * 1  0/40 (0.00%)  0 0/39 (0.00%)  0 1/39 (2.56%)  1 0/39 (0.00%)  0
1
Term from vocabulary, MedRA 17.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
50 mg of X-82 Plus Ivt Anti-VEGF Prn 100 mg of X-82 Plus Ivt Anti-VEGF Prn 200 mg of X-82 Plus Ivt Anti-VEGF Prn Placebo Plus Ivt Anti-VEGF Prn
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/40 (97.50%)      38/39 (97.44%)      37/39 (94.87%)      34/39 (87.18%)    
Cardiac disorders         
Atrioventricular block * 1  3/40 (7.50%)  1/39 (2.56%)  2/39 (5.13%)  3/39 (7.69%) 
Supraventricular systole * 1  2/40 (5.00%)  2/39 (5.13%)  0/39 (0.00%)  0/39 (0.00%) 
Eye disorders         
Conjunctival hemorrhage * 1  2/40 (5.00%)  2/39 (5.13%)  2/39 (5.13%)  2/39 (5.13%) 
Vitreous detachment * 1  3/40 (7.50%)  2/39 (5.13%)  2/39 (5.13%)  1/39 (2.56%) 
Cataract * 1  2/40 (5.00%)  1/39 (2.56%)  2/39 (5.13%)  2/39 (5.13%) 
Retinal hemorrhage * 1  2/40 (5.00%)  2/39 (5.13%)  1/39 (2.56%)  1/39 (2.56%) 
Dry eye * 1  0/40 (0.00%)  1/39 (2.56%)  2/39 (5.13%)  2/39 (5.13%) 
Visual acuity reduced * 1  2/40 (5.00%)  2/39 (5.13%)  1/39 (2.56%)  0/39 (0.00%) 
Neovascular age related macular degeneration * 1  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  3/39 (7.69%) 
Vitreous floaters * 1  2/40 (5.00%)  2/39 (5.13%)  0/39 (0.00%)  0/39 (0.00%) 
Diplopia * 1  2/40 (5.00%)  0/39 (0.00%)  0/39 (0.00%)  1/39 (2.56%) 
Eye irritation * 1  0/40 (0.00%)  1/39 (2.56%)  0/39 (0.00%)  2/39 (5.13%) 
Photopsia * 1  0/40 (0.00%)  2/39 (5.13%)  0/39 (0.00%)  1/39 (2.56%) 
Vision blurred * 1  0/40 (0.00%)  1/39 (2.56%)  2/39 (5.13%)  0/39 (0.00%) 
Eye pain * 1  0/40 (0.00%)  2/39 (5.13%)  0/39 (0.00%)  0/39 (0.00%) 
Eyelash discoloration * 1  0/40 (0.00%)  0/39 (0.00%)  2/39 (5.13%)  0/39 (0.00%) 
Metamorphopsia * 1  0/40 (0.00%)  2/39 (5.13%)  0/39 (0.00%)  0/39 (0.00%) 
Gastrointestinal disorders         
Diarrhoea * 1  1/40 (2.50%)  4/39 (10.26%)  9/39 (23.08%)  2/39 (5.13%) 
nausea * 1  6/40 (15.00%)  2/39 (5.13%)  1/39 (2.56%)  1/39 (2.56%) 
vomiting * 1  3/40 (7.50%)  2/39 (5.13%)  2/39 (5.13%)  1/39 (2.56%) 
dyspepsia * 1  1/40 (2.50%)  2/39 (5.13%)  3/39 (7.69%)  1/39 (2.56%) 
abdominal discomfort * 1  1/40 (2.50%)  1/39 (2.56%)  3/39 (7.69%)  0/39 (0.00%) 
Constipation * 1  2/40 (5.00%)  0/39 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Eructation * 1  0/40 (0.00%)  0/39 (0.00%)  2/39 (5.13%)  0/39 (0.00%) 
General disorders         
Fatigue * 1  2/40 (5.00%)  4/39 (10.26%)  6/39 (15.38%)  0/39 (0.00%) 
Oedema peripheral * 1  1/40 (2.50%)  1/39 (2.56%)  3/39 (7.69%)  1/39 (2.56%) 
Chest pain * 1  0/40 (0.00%)  1/39 (2.56%)  3/39 (7.69%)  0/39 (0.00%) 
Infections and infestations         
Nasopharyngitis * 1  7/40 (17.50%)  2/39 (5.13%)  5/39 (12.82%)  2/39 (5.13%) 
Urinary tract infection * 1  2/40 (5.00%)  5/39 (12.82%)  1/39 (2.56%)  2/39 (5.13%) 
Bronchitis * 1  2/40 (5.00%)  2/39 (5.13%)  3/39 (7.69%)  0/39 (0.00%) 
Influenza * 1  1/40 (2.50%)  1/39 (2.56%)  3/39 (7.69%)  2/39 (5.13%) 
Sinusitis * 1  1/40 (2.50%)  1/39 (2.56%)  2/39 (5.13%)  1/39 (2.56%) 
Upper respiratory tract infection * 1  0/40 (0.00%)  3/39 (7.69%)  1/39 (2.56%)  1/39 (2.56%) 
Pneumonia * 1  1/40 (2.50%)  0/39 (0.00%)  1/39 (2.56%)  2/39 (5.13%) 
Diverticulitis * 1  0/40 (0.00%)  2/39 (5.13%)  0/39 (0.00%)  0/39 (0.00%) 
Tinea cruris * 1  2/40 (5.00%)  0/39 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Injury, poisoning and procedural complications         
Contusion * 1  0/40 (0.00%)  2/39 (5.13%)  3/39 (7.69%)  0/39 (0.00%) 
Fall * 1  1/40 (2.50%)  2/39 (5.13%)  0/39 (0.00%)  0/39 (0.00%) 
Investigations         
Alanine aminotransferase increased * 1  8/40 (20.00%)  11/39 (28.21%)  9/39 (23.08%)  2/39 (5.13%) 
Aspartate aminotransferase increased * 1  6/40 (15.00%)  10/39 (25.64%)  8/39 (20.51%)  1/39 (2.56%) 
Blood pressure increased * 1  2/40 (5.00%)  2/39 (5.13%)  4/39 (10.26%)  3/39 (7.69%) 
Bllod creatinine phosphokinase increased * 1  1/40 (2.50%)  3/39 (7.69%)  3/39 (7.69%)  2/39 (5.13%) 
Blood glucose increased * 1  2/40 (5.00%)  2/39 (5.13%)  2/39 (5.13%)  1/39 (2.56%) 
Hepatic enzyme increase * 1  1/40 (2.50%)  3/39 (7.69%)  3/39 (7.69%)  0/39 (0.00%) 
Platelet count decreased * 1  1/40 (2.50%)  2/39 (5.13%)  3/39 (7.69%)  1/39 (2.56%) 
Urine protein/creatinine ratio increased * 1  2/40 (5.00%)  3/39 (7.69%)  0/39 (0.00%)  1/39 (2.56%) 
White blood cell count decreased * 1  1/40 (2.50%)  3/39 (7.69%)  1/39 (2.56%)  1/39 (2.56%) 
Urine analysis abnormal * 1  0/40 (0.00%)  1/39 (2.56%)  0/39 (0.00%)  2/39 (5.13%) 
Weight decreased * 1  0/40 (0.00%)  0/39 (0.00%)  3/39 (7.69%)  0/39 (0.00%) 
White blood cells urine positive * 1  0/40 (0.00%)  1/39 (2.56%)  0/39 (0.00%)  2/39 (5.13%) 
Prostate specific antigen increased * 1  0/40 (0.00%)  0/39 (0.00%)  2/39 (5.13%)  0/39 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  0/40 (0.00%)  1/39 (2.56%)  4/39 (10.26%)  0/39 (0.00%) 
Vitamin D deficiency * 1  1/40 (2.50%)  0/39 (0.00%)  2/39 (5.13%)  0/39 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle spasms * 1  3/40 (7.50%)  2/39 (5.13%)  3/39 (7.69%)  2/39 (5.13%) 
Back pain * 1  1/40 (2.50%)  3/39 (7.69%)  1/39 (2.56%)  1/39 (2.56%) 
Arthralgia * 1  1/40 (2.50%)  2/39 (5.13%)  0/39 (0.00%)  1/39 (2.56%) 
Pain in extremity * 1  1/40 (2.50%)  2/39 (5.13%)  1/39 (2.56%)  0/39 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Squamous cell carcinoma * 1  1/40 (2.50%)  0/39 (0.00%)  0/39 (0.00%)  2/39 (5.13%) 
Nervous system disorders         
Dysgeusia * 1  3/40 (7.50%)  5/39 (12.82%)  10/39 (25.64%)  0/39 (0.00%) 
Headache * 1  3/40 (7.50%)  2/39 (5.13%)  4/39 (10.26%)  1/39 (2.56%) 
Dizziness * 1  2/40 (5.00%)  3/39 (7.69%)  1/39 (2.56%)  1/39 (2.56%) 
Ageusia * 1  0/40 (0.00%)  0/39 (0.00%)  3/39 (7.69%)  0/39 (0.00%) 
Syncope * 1  0/40 (0.00%)  2/39 (5.13%)  0/39 (0.00%)  1/39 (2.56%) 
Psychiatric disorders         
Depression * 1  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  2/39 (5.13%) 
Insomnia * 1  2/40 (5.00%)  0/39 (0.00%)  0/39 (0.00%)  0/39 (0.00%) 
Renal and urinary disorders         
Haematuria * 1  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  2/39 (5.13%) 
Nephrolithiasis * 1  0/40 (0.00%)  2/39 (5.13%)  1/39 (2.56%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  1/40 (2.50%)  2/39 (5.13%)  3/39 (7.69%)  0/39 (0.00%) 
Sinus congestion * 1  0/40 (0.00%)  2/39 (5.13%)  1/39 (2.56%)  0/39 (0.00%) 
Skin and subcutaneous tissue disorders         
Hair color change * 1  2/40 (5.00%)  10/39 (25.64%)  13/39 (33.33%)  0/39 (0.00%) 
Alopecia * 1  1/40 (2.50%)  2/39 (5.13%)  6/39 (15.38%)  0/39 (0.00%) 
Vascular disorders         
Hypertension * 1  2/40 (5.00%)  4/39 (10.26%)  5/39 (12.82%)  3/39 (7.69%) 
1
Term from vocabulary, MedRA 17.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Vice President, Clinical and Regulatory
Organization: Brace Pharma Capital
Phone: 240-403-7153
Responsible Party: Tyrogenex
ClinicalTrials.gov Identifier: NCT02348359     History of Changes
Other Study ID Numbers: X82-OPH-201
First Submitted: January 21, 2015
First Posted: January 28, 2015
Results First Submitted: May 30, 2018
Results First Posted: June 27, 2018
Last Update Posted: July 25, 2018