Not provided
Not provided
Not provided
Not provided
Not provided
Interim analysis found study had achieved primary objective
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| SynteractHCR | INDUSTRY |
| International Drug Development Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.
Subjects will be randomized in a 1:1:1:1 ratio to the following dose groups:
Subjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo.
Primary Efficacy Outcome:
The primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks after randomization.
Safety Outcomes:
Systemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse events and serious adverse events.
Approximately 132 subjects will be randomized into one of the four arms (33 subjects per dose group).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 mg of X-82 plus ivt anti-VEGF prn | Experimental | 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. |
|
| 100 mg of X-82 plus ivt anti-VEGF prn | Experimental | 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. |
|
| 200 mg of X-82 plus ivt anti-VEGF prn | Experimental | 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. |
|
| Placebo plus ivt anti-VEGF prn | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X-82 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity Score From Day -1 to Week52 | The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization. | Week 52 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel E Salazar, PhD | Study PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | United States | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 50 mg of X-82 Plus Ivt Anti-VEGF Prn | 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 |
| FG001 | 100 mg of X-82 Plus Ivt Anti-VEGF Prn |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2017 | May 25, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Anti-VEGF | Drug |
|
|
| Placebo | Drug |
|
| Beverly Hills |
| California |
| United States |
| Huntington Beach | California | United States |
| Redlands | California | United States |
| Sacramento | California | United States |
| Colorado Springs | Colorado | United States |
| Golden | Colorado | United States |
| New London | Connecticut | United States |
| Fort Myers | Florida | United States |
| Lakeland | Florida | United States |
| Melbourne | Florida | United States |
| Miami | Florida | United States |
| Palm Beach Gardens | Florida | United States |
| Augusta | Georgia | United States |
| Lemont | Illinois | United States |
| Oak Forest | Illinois | United States |
| Indianapolis | Indiana | United States |
| Baltimore | Maryland | United States |
| Glen Burnie | Maryland | United States |
| Boston | Massachusetts | United States |
| Springfield | Massachusetts | United States |
| Portsmouth | New Hampshire | United States |
| Bloomfield | New Jersey | United States |
| Albany | New York | United States |
| New York | New York | United States |
| Asheville | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Cleveland | Ohio | United States |
| Youngstown | Ohio | United States |
| Nashville | Tennessee | United States |
| Abilene | Texas | United States |
| Austin | Texas | United States |
| Houston | Texas | United States |
| The Woodlands | Texas | United States |
| Richmond | Virginia | United States |
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 |
| FG002 | 200 mg of X-82 Plus Ivt Anti-VEGF Prn | 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 |
| FG003 | Placebo Plus Ivt Anti-VEGF Prn | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
All randomized subjects
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 50 mg of X-82 Plus Ivt Anti-VEGF Prn | 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 |
| BG001 | 100 mg of X-82 Plus Ivt Anti-VEGF Prn | 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 |
| BG002 | 200 mg of X-82 Plus Ivt Anti-VEGF Prn | 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 |
| BG003 | Placebo Plus Ivt Anti-VEGF Prn | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Best corrected visual acuity | Mean | Standard Deviation | Number of letters |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Visual Acuity Score From Day -1 to Week52 | The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization. | Analysis restricted to subjects who completed 52 weeks of treatment | Posted | Mean | Standard Deviation | number of letters | Week 52 |
|
|
|
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
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 50 mg of X-82 Plus Ivt Anti-VEGF Prn | 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 | 0 | 40 | 6 | 40 | 39 | 40 |
| EG001 | 100 mg of X-82 Plus Ivt Anti-VEGF Prn | 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 | 1 | 39 | 7 | 39 | 38 | 39 |
| EG002 | 200 mg of X-82 Plus Ivt Anti-VEGF Prn | 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 | 0 | 39 | 3 | 39 | 37 | 39 |
| EG003 | Placebo Plus Ivt Anti-VEGF Prn | 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 | 0 | 39 | 2 | 39 | 34 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| sudden cardiac death | Cardiac disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Endopthalmitis | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedRA 17.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | Non-systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | Non-systematic Assessment |
| |
| B cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | Non-systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedRA 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block | Cardiac disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Supraventricular systole | Cardiac disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Conjunctival hemorrhage | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Retinal hemorrhage | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Neovascular age related macular degeneration | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Eyelash discoloration | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Metamorphopsia | Eye disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| dyspepsia | Gastrointestinal disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| abdominal discomfort | Gastrointestinal disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedRA 17.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedRA 17.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedRA 17.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| Bllod creatinine phosphokinase increased | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increase | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| Urine protein/creatinine ratio increased | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| Prostate specific antigen increased | Investigations | MedRA 17.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 17.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Hair color change | Skin and subcutaneous tissue disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedRA 17.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedRA 17.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical and Regulatory | Brace Pharma Capital | 240-403-7153 | info@Tyrogenex.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2017 | May 30, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| C566935 | Macular Degeneration, Age-Related, 10 |
| D005128 | Eye Diseases |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000069579 | Ranibizumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|