Not provided
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Primary, 8-week efficacy endpoint not achieved. No additional benefit for subjects receiving a corticosteroid together with an intravitreal anti-VEGF agent.
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This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.
A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections |
|
| Control | Active Comparator | IVT aflibercept (2 mg/0.05 mL) + sham SC procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suprachoroidal CLS-TA | Drug | suprachoroidal injection of CLS-TA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) | Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity | Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Ciulla, MD MBA | Clearside Biomedical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants, Ltd. | Peoria | Arizona | 85381 | United States | ||
| Retinal Consultants of Arizona and Retinal Research Institute |
Not provided
Not provided
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active | IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA IVT aflibercept: 2 mg intravitreal injection of aflibercept |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
| suprachoroidal sham | Drug | suprachoroidal sham procedure |
|
| IVT aflibercept | Drug | 2 mg intravitreal injection of aflibercept |
|
|
| 6 months |
| Mean Change From Baseline in Central Subfield Thickness | Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. | 6 months |
| Phoenix |
| Arizona |
| 85014-2709 |
| United States |
| Arizona Retina and Vitreous Consultants | Phoenix | Arizona | 85021 | United States |
| Associated Retina Consultants, Ltd. | Phoenix | Arizona | 85381 | United States |
| Retina Centers P.C. | Tucson | Arizona | 85704 | United States |
| California Retina Research Consultants | Bakersfield | California | 93309 | United States |
| Retina Vitreous Medical Group Clinical Research | Beverly Hills | California | 90211-1841 | United States |
| Atlantis Eyecare | Huntington Beach | California | 92647 | United States |
| Jacobs Retina Center at the Shiley Eye Institute, UCSD | La Jolla | California | 92093 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| East Bay Retina Consultants Inc. | Oakland | California | 95409 | United States |
| Southern California Desert Retina Consultants | Palm Desert | California | 92211 | United States |
| Retina Institute of California | Palm Desert | California | 92260 | United States |
| Retina Consultants San Diego | Poway | California | 92064-2526 | United States |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | United States |
| California Retina Consultants CRC | Santa Barbara | California | 93103 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94599 | United States |
| Colorado Retina Associates | Golden | Colorado | 80401 | United States |
| New England Retina Associates | Hamden | Connecticut | 06518 | United States |
| MedEye Associates | Miami | Florida | 33143-5188 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Emory Eye Center | Atlanta | Georgia | 30322 | United States |
| Southeast Retina Center, PC | Augusta | Georgia | 30909 | United States |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | United States |
| Retina Consultants of Hawaii | ‘Aiea | Hawaii | 96701 | United States |
| Illinois Eye and Ear Infirmary, UIC | Chicago | Illinois | 60612 | United States |
| Illinois Retina Associates | Chicago | Illinois | 60657 | United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Retina Associates, PA | Shawnee Mission | Kansas | 66204 | United States |
| Retina and Vitrous Associates of Kentucky | Lexington | Kentucky | 40509 | United States |
| Wilmer Eye Institute John Hopkins University | Baltimore | Maryland | 21287-0005 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740-5940 | United States |
| The Retina Institute | St Louis | Missouri | 63128 | United States |
| Retina Associates of NJ | Teaneck | New Jersey | 07666 | United States |
| Western Carolina Retinal Associates, PA | Asheville | North Carolina | 28803 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Cleveland Clinic Foundation/Cole Eye Institute | Cleveland | Ohio | 44195 | United States |
| Oregon Retina Institute | Medford | Oregon | 97504 | United States |
| Casey Eye Institute/Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701-7374 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606-1224 | United States |
| Texas Retina Associates-Arlington | Arlington | Texas | 76012-2505 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240-1502 | United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| University of Utah HSC - John A. Moran Eye Center | Salt Lake City | Utah | 84132 | United States |
| Retina Institute of Virginia | Richmond | Virginia | 23235 | United States |
| Virginia Retina Center | Warrenton | Virginia | 20186 | United States |
| University of Wisconsin-Madison | Madison | Wisconsin | 53705 | United States |
| Strathfield Retina Clinic | Strathfield | New South Wales | 2135 | Australia |
| Save Site Institute, University of Sydney, Sydney Eye Hospital | Sydney | New South Wales | 2000 | Australia |
| Sydney Retina Clinic and Day Surgery | Sydney | New South Wales | 2000 | Australia |
| Marsden Eye Specialists | Sydney | New South Wales | 2150 | Australia |
| The Royal Victorian Eye and Ear Hospital | East Melbourne | Victoria | 3002 | Australia |
| Specialist Eye Group | Melbourne | Victoria | 3150 | Australia |
| University of Graz-Department of Ophthalmology | Graz | Austria |
| Kepler University Hospital | Linz | Austria |
| UBC/VGH Eye Care Centre | Vancouver | British Columbia | V5Z 3N9 | Canada |
| St. Joseph's Health Care London, Ivey Eye Institute | London | Ontario | N6A 4V2 | Canada |
| University of Ottawa Eye Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Institut de l'oeil des Laurentides | Boisbriand | Quebec | J7H 1S6 | Canada |
| CIUSSS de l'Est-de-l'Ile-de-Montreal. Hospital Maisonneuve-Rosemont, Comite d'ethique de la recherche | Montreal | Quebec | H1T 2M4 | Canada |
| Rigshospitalet | Glostrup Municipality | Denmark |
| Dept. of Ophthalmology, Sjællands Universitetshospital, Roskilde | Roskilde | Denmark |
| Semmelweis Egyetem, Szemeszeti Klinika | Budapest | 1083 | Hungary |
| Bajcsy-Zsilinszky Korhaz es Rendelointezet, Szemeszeti Osztaly | Budapest | 1106 | Hungary |
| Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | 1162 | Hungary |
| Budapest Retina Associates | Budapest | Hungary |
| Debreceni Egyetem Klinikai Kozpont, Szemklinika | Debrecen | 4032 | Hungary |
| Ganglion Orvosi Kozpont | Pécs | 7621 | Hungary |
| M&J Western Regional Institute of Ophthalmology | Ahmedabad | Gujarat | 380016 | India |
| T.N. Medical College and B.Y.L. Nair Charitable Hospital | Mumbai | Maharashtra | 400008 | India |
| Department of Medical Ophthalmology, Retina & Uvea | Delhi | New Delhi | 110029 | India |
| Aravind Eye Hospitals & Postgraduate Institute of Ophthalmology | Madurai | Tamil Nadu | 625020 | India |
| Smt. Kanuri Santhamma Centre for Vitreo Retinal Diseases | Hyderabad | Telangana | 500034 | India |
| Disha Eye Hospital Private Limited | Kolkata | West Bengal | 700120 | India |
| Bnai Zion Medical Center | Haifa | 3104802 | Israel |
| ASST Fatebenefratelli Sacco - P.O.L., University of Milan, Dep. of Ophthalmology | Milan | 20157 | Italy |
| Cebu Doctor's University Hospital | Cebu City | 6000 | Philippines |
| Peregrine Eye & Laser Institute | Makati City | 1209 | Philippines |
| The Medical City | Pasig | 1600 | Philippines |
| Oftalmika sp. z o. o. | Bydgoszcz | 85-631 | Poland |
| Optimum Profesorskie Centrum Okulistyki | Gdansk | 80-809 | Poland |
| Uniwersytet Medyczny w Lublinie | Lublin | 20-079 | Poland |
| Centrum Diagnostyki i Mikrochirurgii Oka Lens | Olsztyn | 10-424 | Poland |
| Centro Clinico Academico Braga - 2CA-Braga | Braga | 4710-243 | Portugal |
| Centro Hospitalar e Universitario de Coimbra, E.P.E. | Coimbra | 3000-075 | Portugal |
| Centro Hospitalar de Sao Joao, E.P.E. | Porto | 4200-319 | Portugal |
| Fakultna nemocnica s poliklinikou Zilina | Žilina | 01207 | Slovakia |
| Instituto Cinico Quirurgico de Oftalmologia | Bilbao | Vizcaya | 48006 | Spain |
| Hospital General de Catalunya | Barcelona | Spain |
| Hospital Universitari de Bellvitge | Barcelona | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Instituto Oftalmologico Fernandez-Vega | Oviedo | 33012 | Spain |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Hospital Clinico Universitario | Zaragoza | Spain |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Queens University Royal Victoria Hospital Trust | Belfast | BT12 6BJ | United Kingdom |
| Sunderland Eye Infirmary | Sunderland | United Kingdom |
IVT aflibercept (2 mg/0.05 mL) + sham SC procedure
suprachoroidal sham: suprachoroidal sham procedure
IVT aflibercept: 2 mg intravitreal injection of aflibercept
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety population included all randomly assigned subjects who were administered at least one dose of the study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active | IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA IVT aflibercept: 2 mg intravitreal injection of aflibercept |
| BG001 | Control | IVT aflibercept (2 mg/0.05 mL) + sham SC procedure suprachoroidal sham: suprachoroidal sham procedure IVT aflibercept: 2 mg intravitreal injection of aflibercept |
| BG002 | 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, Categorical | Age of patients in years relative to the date of the Screening visit. | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | Age of patients in years relative to the date of the Screening visit. | Mean | Standard Deviation | Years |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Type of Retinal Vein Occlusion | Count of Participants | Participants |
|
| 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 | Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) | Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. | The Intent-to-treat population included all randomized subjects who received at least one study treatment. | Posted | Count of Participants | Participants | 2 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Best Corrected Visual Acuity | Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision. | The Intent-to-treat population included all randomized subjects who received at least one study treatment. | Posted | Least Squares Mean | Standard Error | Letters | 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Central Subfield Thickness | Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. | The Intent-to-treat population included all randomized subjects who received at least one study treatment. | Posted | Least Squares Mean | Standard Error | Microns | 6 months |
|
|
Adverse events were collected over 48 weeks of follow-up.
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 | Active | IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA IVT aflibercept: 2 mg intravitreal injection of aflibercept | 0 | 231 | 25 | 231 | 128 | 231 |
| EG001 | Control | IVT aflibercept (2 mg/0.05 mL) + sham SC procedure suprachoroidal sham: suprachoroidal sham procedure IVT aflibercept: 2 mg intravitreal injection of aflibercept | 0 | 229 | 28 | 229 | 83 | 229 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | #Fellow eye |
|
| Retinal detachment | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | #Study eye |
|
| Ulcerative keratitis | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | #Study eye |
|
| Visual acuity reduced | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | #Study eye |
|
| Vitreous haemorrhage | Eye disorders | MedDRA (19.0) | Non-systematic Assessment | #Study eye |
|
| Gastritis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abasia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment | #Study eye |
|
| Hepatitis C | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (19.0) | Non-systematic Assessment | #Study eye |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rotor cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Paraganglion neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Aortic arteriosclerosis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
Due to the early termination of the trial by sponsor all planned study visits were not completed by all treated subjects; therefore, all planned data was not collected.
The institutions and Investigators participating in this study shall have no right to publish or present the results of this study without the prior written consent of Clearside Biomedical, Inc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Ciulla, MD MBA | Clearside Biomedical, Inc. | (678) 392-2318 | thomas.ciulla@clearsidebio.com |
| Feb 18, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| C533178 | aflibercept |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Philippines |
|
| United Kingdom |
|
| Portugal |
|
| India |
|
| Spain |
|
| Canada |
|
| Taiwan |
|
| Denmark |
|
| Poland |
|
| Slovakia |
|
| Australia |
|
| Central retinal vein occlusion |
|
Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint. |
| Superiority |
|
|