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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004132-37 | EudraCT Number |
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Age-related macular degeneration (AMD) is a leading cause of vision loss in adults. Abnormal blood vessels grow under the macula at the back of the eye, and also leak blood and fluid, which damages and scars the macula, affecting vision. The current standard of care for patients with neovascular (exudative / wet) AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy, which prevents or slows down the growth of the abnormal blood vessels. SCD411 is being developed as a biosimilar to the reference product Eylea® (aflibercept), an anti-VEGF drug. The study aims to prove equivalence of SCD411 to Eylea in adults with wet AMD, and will look at safety, tolerance, effectiveness, immune response and the movement of the drug through the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCD411 | Experimental |
| |
| Aflibercept | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCD411 | Drug | IVT (intravitreal) injection |
| |
| Aflibercept |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in BCVA (Best Corrected Visual Acuity) | Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in BCVA (Best Corrected Visual Acuity) | Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts | Baseline to Week 52 |
| Percentage of Subjects With Anti-SCD411 Antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung Jhip Ha | Sam Chun Dang Pharm. Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCD Research Site | Campbell | California | 95008 | United States | ||
| SCD Research Site |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
| FDA Recalls, Market Withdrawals, and Safety Alerts | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | SCD411 | SCD411: IVT (intravitreal) injection |
| FG001 | Aflibercept | Aflibercept: IVT injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2022 | Sep 1, 2023 |
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Only the unmasked investigator involved in performing the IVT injections will be unmasked to study treatment. These individuals are not allowed to discuss treatment and/or subject outcome with masked study staff, including the evaluating investigator.
| Drug |
IVT injection |
|
|
Assessed by blood samples
| Baseline, Weeks 4, 8, 20, 36 and 52 |
| Clearwater |
| Florida |
| 33761 |
| United States |
| SCD Research Site | Coral Springs | Florida | 33067 | United States |
| SCD Research Site | Fort Myers | Florida | 33912 | United States |
| SCD Research Site | Stuart | Florida | 34994 | United States |
| SCD Research Site | Marietta | Georgia | 30060 | United States |
| SCD Research Site | Lemont | Illinois | 60439 | United States |
| SCD Research Site | Liverpool | New York | 13088 | United States |
| SCD Research Site | Springfield | Oregon | 97477 | United States |
| SCD Research Site | Rapid City | South Dakota | 57701 | United States |
| SCD Research Site | Abilene | Texas | 79606 | United States |
| SCD Research Site | Willow Park | Texas | 76087 | United States |
| SCD Research Site | Liverpool | New South Wales | 2170 | Australia |
| SCD Research Site | Sydney | New South Wales | 2000 | Australia |
| SCD Research Site | East Melbourne | Victoria | 3002 | Australia |
| SCD Research Site | Nedlands | Western Australia | 6009 | Australia |
| SCD Research Site | Sofia | Sofia-Grad | 1431 | Bulgaria |
| SCD Research Site | Sofia | Sofia-Grad | 1784 | Bulgaria |
| SCD Research Site | Sofia | 1618 | Bulgaria |
| SCD Research Site | Pardubice | Pardubice Region | 530 02 | Czechia |
| SCD Research Site | Prague | 128 08 | Czechia |
| SCD Research Site | Budapest | 1062 | Hungary |
| SCD Research Site | Budapest | 1085 | Hungary |
| SCD Research Site | Budapest | 1133 | Hungary |
| SCD Research Site | Budapest | 1204 | Hungary |
| SCD Research Site | Debrecen | 4032 | Hungary |
| SCD Research Site | Nyíregyháza | 4400 | Hungary |
| SCD Research Site | Pécs | 7621 | Hungary |
| SCD Research Site | Wardha | Maharashtra | 442001 | India |
| SCD Research Site | Bhubaneswar | Odisha | 751024 | India |
| SCD Research Site | Jaipur | Rajasthan | 302015 | India |
| SCD Research Site | Hyderabad | Telangana | 500018 | India |
| SCD Research Site | Lucknow | Uttar Pradesh | 226001 | India |
| SCD Research Site | Kolkata | West Bengal | 700020 | India |
| SCD Research Site | Kolkata | West Bengal | 700073 | India |
| SCD Research Site | Haifa | 31096 | Israel |
| SCD Research Site | Haifa | 34362 | Israel |
| SCD Research Site | Holon | 58100 | Israel |
| SCD Research Site | Jerusalem | 91120 | Israel |
| SCD Research Site | Kfar Saba | 44281 | Israel |
| SCD Research Site | Nahariya | 22100 | Israel |
| SCD Research Site | Petah Tikva | 49100 | Israel |
| SCD Research Site | Ramat Gan | 52621 | Israel |
| SCD Research Site | Rehovot | 76100 | Israel |
| SCD Research Site | Tel Aviv | 64239 | Israel |
| SCD Research Site | Tiberias | 15208 | Israel |
| SCD Research Site | Ẕerifin | 70300 | Israel |
| SCD Research Site | Nagoya | Aiti | 457-8510 | Japan |
| SCD Research Site | Kurume | Hukuoka | 830-0011 | Japan |
| SCD Research Site | Amagasaki | Hyôgo | 660-8550 | Japan |
| SCD Research Site | Kobe | Hyōgo | 650-0047 | Japan |
| SCD Research Site | Nishinomiya | Hyōgo | 663-8501 | Japan |
| SCD Research Site | Kagoshima | Kagoshima-ken | 890-8520 | Japan |
| SCD Research Site | Kyoto | Kyôto | 607-8062 | Japan |
| SCD Research Site | Nakagami | Okinawa | 903-0215 | Japan |
| SCD Research Site | Chuo Ku | Tokyo | 104-8560 | Japan |
| SCD Research Site | Hachiōji | Tokyo | 193-0998 | Japan |
| SCD Research Site | Meguro City | Tokyo | 152-8902 | Japan |
| SCD Research Site | Nerima-ku | Tokyo | 177-8521 | Japan |
| SCD Research Site | Ube | Yamaguchi | 755-8505 | Japan |
| SCD Research Site | Fukuoka | 812-0011 | Japan |
| SCD Research Site | Fukushima | 960-1295 | Japan |
| SCD Research Site | Kita-ku | 761-0793 | Japan |
| SCD Research Site | Nagakute | 480-1195 | Japan |
| SCD Research Site | Niigata | 951-8520 | Japan |
| SCD Research Site | Saga | 849-8501 | Japan |
| SCD Research Site | Sakai | 593-8304 | Japan |
| SCD Research Site | Sakura | 285-8741 | Japan |
| SCD Research Site | Toyama | 930-0194 | Japan |
| SCD Research Site | Jelgava | LV-3001 | Latvia |
| SCD Research Site | Riga | LV-1002 | Latvia |
| SCD Research Site | Riga | LV-1006 | Latvia |
| SCD Research Site | Riga | LV-1009 | Latvia |
| SCD Research Site | Wałbrzych | Lower Silesian Voivodeship | 58-309 | Poland |
| SCD Research Site | Wroclaw | Lower Silesian Voivodeship | 50-556 | Poland |
| SCD Research Site | Wroclaw | Lower Silesian Voivodeship | 50-981 | Poland |
| SCD Research Site | Warsaw | Masovian Voivodeship | 01-258 | Poland |
| SCD Research Site | Warsaw | Masovian Voivodeship | 01-364 | Poland |
| SCD Research Site | Rzeszów | Podkarpackie Voivodeship | 35-017 | Poland |
| SCD Research Site | Gdansk | Pomeranian Voivodeship | 80-809 | Poland |
| SCD Research Site | Katowice | Silesian Voivodeship | 40-514 | Poland |
| SCD Research Site | Katowice | Silesian Voivodeship | 40-594 | Poland |
| SCD Research Site | Olsztyn | Warminsko-marzurskie | 10-424 | Poland |
| SCD Research Site | Bydgoszcz | 85-631 | Poland |
| SCD Research Site | Bydgoszcz | 85-870 | Poland |
| SCD Research Site | Lublin | 20-079 | Poland |
| SCD Research Site | Warsaw | 00-215 | Poland |
| SCD Research Site | Moscow | 101750 | Russia |
| SCD Research Site | Moscow | 127473 | Russia |
| SCD Research Site | Moscow | 127486 | Russia |
| SCD Research Site | Novosibirsk | 630087 | Russia |
| SCD Research Site | Bratislava | 826 06 | Slovakia |
| SCD Research Site | Poprad | 058 45 | Slovakia |
| SCD Research Site | Trebišov | 075 01 | Slovakia |
| SCD Research Site | Žilina | 012 07 | Slovakia |
| SCD Research Site | Guri-si | Gyeonggido | 11923 | South Korea |
| SCD Research Site | Suwon | Gyeonggido | 16499 | South Korea |
| SCD Research Site | Changwon-Si | Gyeongsangnam-do | 51472 | South Korea |
| SCD Research Site | Cheongju-si | North Chungcheong | 28644 | South Korea |
| SCD Research Site | Busan | 48108 | South Korea |
| SCD Research Site | Busan | 49201 | South Korea |
| SCD Research Site | Busan | 49241 | South Korea |
| SCD Research Site | Busan | 49267 | South Korea |
| SCD Research Site | Daegu | 41944 | South Korea |
| SCD Research Site | Daegu | 42415 | South Korea |
| SCD Research Site | Daegu | 42601 | South Korea |
| SCD Research Site | Daejeon | 35015 | South Korea |
| SCD Research Site | Daejeon | 35365 | South Korea |
| SCD Research Site | Gwangju | 61469 | South Korea |
| SCD Research Site | Incheon | 21565 | South Korea |
| SCD Research Site | Incheon | 22332 | South Korea |
| SCD Research Site | Jinju | 52727 | South Korea |
| SCD Research Site | Seoul | 02447 | South Korea |
| SCD Research Site | Seoul | 02841 | South Korea |
| SCD Research Site | Seoul | 03080 | South Korea |
| SCD Research Site | Seoul | 05355 | South Korea |
| SCD Research Site | Seoul | 05505 | South Korea |
| SCD Research Site | Seoul | 06198 | South Korea |
| SCD Research Site | Seoul | 06351 | South Korea |
| SCD Research Site | Seoul | 07441 | South Korea |
| SCD Research Site | Seoul | 7061 | South Korea |
| SCD Research Site | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| SCD Research Site | Barcelona | 08022 | Spain |
| SCD Research Site | Barcelona | 08025 | Spain |
| SCD Research Site | Bilbao | 48006 | Spain |
| SCD Research Site | Bilbao | 48010 | Spain |
| SCD Research Site | Majadahonda | 28222 | Spain |
| SCD Research Site | Valencia | 46014 | Spain |
| SCD Research Site | Valladolid | 47012 | Spain |
| SCD Research Site | Zaragoza | 50009 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Included all randomized subjects who received at least 1 injection of the IP. Numbers were based on planned treatment group. Two subjects met the exclusion criteria but were randomized in error; however, they did not receive any IP injection. A third subject also did not receive any IP injection. These 3 subjects were excluded from all analyses sets.
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| ID | Title | Description |
|---|---|---|
| BG000 | SCD411 | SCD411: IVT (intravitreal) injection |
| BG001 | Aflibercept | Aflibercept: IVT injection |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | A subject from the SCD411 group had missing vital sign data (including body weight and height) | Mean | Standard Deviation | kilograms |
| ||||||||||||||
| Height | A subject from the SCD411 group had missing vital sign data (including body weight and height) | Mean | Standard Deviation | centimeters |
| ||||||||||||||
| BMI | A subject from the SCD411 group had missing vital sign data (including body weight and height) | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Best Corrected Visual Acuity (BCVA) | Mean | Standard Deviation | Letters correctly read |
|
| 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 | Change From Baseline in BCVA (Best Corrected Visual Acuity) | Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts | The Full Analysis Set included all randomized subjects who received at least 1 injection of the study drug. | Posted | Mean | 95% Confidence Interval | Letters correctly read | Baseline to Week 8 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in BCVA (Best Corrected Visual Acuity) | Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts | The Full Analysis Set included all randomized subjects who received at least 1 injection of the study drug. | Posted | Mean | 95% Confidence Interval | Letters correctly read | Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Anti-SCD411 Antibodies | Assessed by blood samples | The Safety Set included all subjects who received at least 1 injection of the study drug. | Posted | Number | Percentage of participants | Baseline, Weeks 4, 8, 20, 36 and 52 |
|
|
Adverse events were assessed beginning at enrollment (date of signed informed consent) and up to 28 days after the last dose of the study drug, up to Day 365.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SCD411 | SCD411: IVT (intravitreal) injection | 0 | 287 | 32 | 287 | 128 | 287 |
| EG001 | Aflibercept | Aflibercept: IVT injection | 1 | 286 | 30 | 286 | 121 | 286 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Retinal pigment epithelial tear | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Amaurosis fugax | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Retinal haemorrhage | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Endophthalmitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Visual acuity reduced | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Fellow eye |
|
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Aspergilloma | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Bone tuberculosis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Venom poisoning | Injury, poisoning and procedural complications | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| High-grade B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Lung adenocarcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 23.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Intracranial mass | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA Version 23.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Age-related macular degeneration | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Fellow Eye |
|
| Blepharitis | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Blepharitis | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Fellow Eye |
|
| Cataract | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Cataract | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Fellow Eye |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Fellow Eye |
|
| Corneal erosion | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Dry eye | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Dry eye | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Fellow Eye |
|
| Eye pain | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Lacrimation increased | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Neovascular age-related macular degeneration | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Neovascular age-related macular degeneration | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Fellow Eye |
|
| Ocular hypertension | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Posterior capsule opacification | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Punctate keratitis | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Retinal haemorrhage | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Subretinal fluid | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Visual acuity reduced | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Visual impairment | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Visual impairment | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Fellow Eye |
|
| Vitreous detachment | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Vitreous floaters | Eye disorders | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Conjunctivitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment | Fellow Eye |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 23.0 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA Version 23.0 | Systematic Assessment | Study Eye |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 23.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 23.0 | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Byung Jhip Ha, Director of Bio Research Center | SamChunDang Pharm. Co. Ltd. | +82-31-869-7327 | scd411clinical@scd.co.kr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2022 | Aug 31, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
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| 65 to less than 75 years |
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| Greater than or equal to 75 years |
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| Bulgaria |
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| Czechia |
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| Hungary |
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| India |
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| Israel |
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| Japan |
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| Latvia |
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| Poland |
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| South Korea |
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| Russia |
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| Slovakia |
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| Spain |
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| United States |
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| Title |
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| Denominators |
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| Categories |
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| Baseline : Positive |
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| Baseline : Negative |
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| Week 4 : Positive |
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| Week 4 : Negative |
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| Week 8 : Positive |
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| Week 8 : Negative |
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| Week 20 : Positive |
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| Week 20 : Negative |
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| Week 36 : Positive |
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| Week 36 : Negative |
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| Week 52 : Positive |
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| Week 52 : Negative |
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