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Primary Endpoint Not Met
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This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).
This study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg and aflibercept 2 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSI-301 5 mg | Experimental | Drug: KSI-301 5 mg. KSI-301 5 mg will be administered by intravitreal injection into the study eye at 12, 16, and 20 weeks intervals as specified in the study protocol. Drug: Sham Procedure. The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. |
|
| Aflibercept 2 mg | Active Comparator | Drug: Aflibercept 2 mg. Aflibercept 2 mg will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks. Drug: Sham Procedure. The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KSI-301 | Drug | Intravitreal Injection |
| |
| Aflibercept |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set Year 1 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. | Year 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects on KSI-301 Arm With a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval | Percentage of subjects on KSI-301 arm achieving a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval based on individualized treatment response | Year 1 |
| Percentage of Subjects Gaining ≥ 5, ≥10 and ≥15 Letters in BCVA From Baseline in the Study Eye, Full Analysis Set Year 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Velazquez-Martin, MD | Kodiak Sciences Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Research Institute, LLC | Phoenix | Arizona | 85014 | United States | ||
| Northwest Arkansas Retina Associates |
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Of 785 participants screened, 559 were randomized to treatment. Two randomized subjects (one subject in KSI-301 arm and one subject in aflibercept arm) never received treatment, so do not have reason for not completing treatment.
Participants were recruited based on physician referral at 72 medical centers between September 2019 and November 2020. The first participant was enrolled on 08 October 2019 and the last on 24 November 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | KSI-301 5 mg Q12W-Q20W | Participants randomized to this arm received 5 milligrams (mg) KSI-301 intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 8, followed by 5 mg KSI-301 IVT injections based on disease activity assessments and may vary from Q12W to Q20W until Week 52. |
| FG001 |
| 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 | Jun 2, 2021 | Apr 4, 2024 |
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A masked evaluating investigator will be responsible for subject care except the injections and the safety assessment following the injections. An unmasked treating investigator will perform the injections and assess patient safety following the injections.
| Drug |
Intravitreal Injection |
|
|
| Sham Procedure | Other | The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. |
|
Categorical improvements in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart |
| Year 1 |
| Percentage of Subjects Who Achieving BCVA Snellen Equivalent of 20/40 or Better in the Study Eye at Year 1 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. BCVA Snellen equivalent of 20/40 was defined as ≥69 ETDRS letters | Year 1 |
| Percentage of Subjects With BCVA Snellen Equivalent of 20/200 or Worse in the Study Eye at Year 1 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. BCVA Snellen equivalent of 20/200 or Worse was defined as BCVA ≤ 38 ETDRS Letters. | Year 1 |
| Mean Change in OCT Central Subfield Retinal Thickness (CST) From Day 1 | Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) as assessed by a central reading center. | Year 1 |
| Springdale |
| Arkansas |
| 72762 |
| United States |
| California Retina Consultants | Bakersfield | California | 93309 | United States |
| Retina Vitreous Associates | Beverly Hills | California | 90211 | United States |
| Eye Medical Center of Fresno | Fresno | California | 93720 | United States |
| Retina Consultants of Orange County | Fullerton | California | 92835 | United States |
| UCSD Jacobs Retina Center | La Jolla | California | 92037 | United States |
| Retina Associates of Orange County | Laguna Hills | California | 92653 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| Retina Consultants of San Diego | Poway | California | 92064 | United States |
| Retinal Consultants Medical Group Inc | Sacramento | California | 95819 | United States |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | United States |
| California Retina Consultants | Santa Maria | California | 93454 | United States |
| Colorado Retina Associates PC | Lakewood | Colorado | 80228 | United States |
| Florida Eye Microsurgical Institute | Boynton Beach | Florida | 33426 | United States |
| Rand Eye Institute | Deerfield Beach | Florida | 33064 | United States |
| Retina Health Center | Fort Myers | Florida | 33907 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33703 | United States |
| Retina Associates of Florida | Tampa | Florida | 33609 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| Retina Associates PA | Lenexa | Kansas | 66215 | United States |
| Vitreo Retinal Consultants and Surgeons | Wichita | Kansas | 67214 | United States |
| Retina Associates of Kentucky | Lexington | Kentucky | 40509 | United States |
| Cumberland Valley Retina Consultants PC | Hagerstown | Maryland | 21740 | United States |
| New England Retina Consultants | Springfield | Massachusetts | 01103 | United States |
| Vitreo Retinal Associates PC | Worcester | Massachusetts | 01603 | United States |
| Foundation for Vision Research | Grand Rapids | Michigan | 49525 | United States |
| Associated Retinal Consultants PC | Royal Oak | Michigan | 78073 | United States |
| Vitreoretinal Surgery PA | Edina | Minnesota | 55435 | United States |
| Springfield Clinic LLP | Springfield | Missouri | 62703 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| The Retina Center of New Jersey | Bloomfield | New Jersey | 07017 | United States |
| NJ Retina | Teaneck | New Jersey | 07605 | United States |
| Retina Associates of Cleveland | Beachwood | Ohio | 44122 | United States |
| Retina Associates of Cleveland | Cleveland | Ohio | 44130 | United States |
| Cleveland Clinic Foundation, Cole Eye Institute | Cleveland | Ohio | 44195 | United States |
| Retina and Vitreous Center of Southern Oregon PC | Ashland | Oregon | 97520 | United States |
| Cascade Medical Research Institute | Eugene | Oregon | 97401 | United States |
| Retina Northwest | Portland | Oregon | 97210 | United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Palmetto Retina Center | Florence | South Carolina | 29501 | United States |
| Charleston Neuroscience Institute | Ladson | South Carolina | 29456 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Southeastern Retina Associates PC | Knoxville | Tennessee | 37909 | United States |
| Tennessee Retina PC | Nashville | Tennessee | 37203 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Austin Clinical Research, LLC | Austin | Texas | 78705 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |
| Retina Consultants of Texas (Katy) | Katy | Texas | 77494 | United States |
| Texas Retina Associates | Plano | Texas | 75075 | United States |
| Austin Retina Associates (Round Rock) | Round Rock | Texas | 78681 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas (Woodlands) | The Woodlands | Texas | 77384 | United States |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | United States |
| Axon Clinical, s.r.o. | Prague | 150 00 | Czechia |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Uniklinik Köln | Cologne | 50937 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitatsklinikum Leipzig | Leipzig | 04103 | Germany |
| Pauls Stradins Clinical University Hospital | Riga | 1002 | Latvia |
| Riga Eastern Clinical University Hospital Clinic Bikernieki | Riga | 1038 | Latvia |
| Oftalmika Sp. z o.o. | Bydgoszcz | 85-631 | Poland |
| Gabinet Okulistyczny prof. E. Wylegala | Katowice | 40-760 | Poland |
| Retina Okulistyka Sp. z o.o. Sp. km. | Warsaw | 01-364 | Poland |
| Univerzitna nemocnica Bratislava | Bratislava | 821 01 | Slovakia |
| Nemocnica Trebisov - SVET ZDRAVIA - PPDS | Trebišov | 075 01 | Slovakia |
| Fakultna nemocnica Trencin | Trenčín | 911 01 | Slovakia |
| Fakultna nemocnica s poliklinikou Zilina | Žilina | 012 07 | Slovakia |
| Institut de La Macula i La Retina | Barcelona | 08022 | Spain |
| Hospital dos de Maig | Barcelona | 08025 | Spain |
| Aflibercept 2 mg Q8W |
Participants randomized to this arm received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 8, followed by 2 mg aflibercept IVT injections Q8W to Week 52. |
| COMPLETED | Completed is defined as participants who completed treatment through Year 1. |
|
| NOT COMPLETED |
|
|
All randomized subjects who received at least one active study treatment (KSI-301 or aflibercept)
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| ID | Title | Description |
|---|---|---|
| BG000 | KSI-301 5 mg Q12W-Q20W | Participants randomized to this arm received 5 milligrams (mg) KSI-301 intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 8, followed by 5 mg KSI-301 IVT injections based on disease activity assessments and may vary from Q12W to Q20W until Week 52. |
| BG001 | Aflibercept 2 mg Q8W | Participants randomized to this arm received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 8, followed by 2 mg aflibercept IVT injections Q8W to Week 52. |
| 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 | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| BCVA in the Study Eye, Letters | Mean | Standard Deviation | 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 | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set Year 1 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. | Full analysis set defined as all randomized subjects who received at least one treatment injection in Year 1. Subjects will be analyzed according to their randomized treatment. | Posted | Least Squares Mean | Standard Error | ETDRS Letters | Year 1 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects on KSI-301 Arm With a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval | Percentage of subjects on KSI-301 arm achieving a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval based on individualized treatment response | Subjects with Available Data at the Planned Durability Assessment at Year 1 | Posted | Count of Participants | Participants | Year 1 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Gaining ≥ 5, ≥10 and ≥15 Letters in BCVA From Baseline in the Study Eye, Full Analysis Set Year 1 | Categorical improvements in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart | All randomized subjects who received at least one treatment injection in Year 1 with available data at Year 1 for analysis. Number of participants in each Row Title is not mutually exclusive as number of participants who gained >=15 ETDRS letters includes participants who gained >=10 ETDRS letters and participants who gained >=5 ETDRS letters. | Posted | Count of Participants | Participants | Year 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Achieving BCVA Snellen Equivalent of 20/40 or Better in the Study Eye at Year 1 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. BCVA Snellen equivalent of 20/40 was defined as ≥69 ETDRS letters | All randomized subjects who received at least one treatment injection in Year 1 with available data at Year 1 for analysis. | Posted | Count of Participants | Participants | Year 1 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With BCVA Snellen Equivalent of 20/200 or Worse in the Study Eye at Year 1 | Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. BCVA Snellen equivalent of 20/200 or Worse was defined as BCVA ≤ 38 ETDRS Letters. | All randomized subjects who received at least one treatment injection in Year 1 with available data at Year 1 for analysis. | Posted | Count of Participants | Participants | Year 1 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Day 1 | Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) as assessed by a central reading center. | Full analysis set defined as all randomized subjects who received at least one treatment injection in Year 1. Subjects will be analyzed according to their randomized treatment. | Posted | Mean | Standard Deviation | Microns | Year 1 |
|
|
Adverse Events (AEs) reported through Week 52 or Early Termination (ET) if occurred before Week 52.
Safety results for the KSI-301 5mg arm are presented together as patients treated with Q12W dosing received 6 total doses in Year 1 and the patients treated with Q20W dosing received 5 total doses in Year 1. Therefore, presenting all treatment intervals together provides a more robust dataset to evaluate the safety profile of KSI-301.
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 | KSI-301 5 mg Q12W-Q20W | Participants randomized to this arm received 5 milligrams (mg) KSI-301 intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 8, followed by 5 mg KSI-301 IVT injections based on disease activity assessments and may vary from Q12W to Q20W until Week 52. | 4 | 277 | 35 | 277 | 82 | 277 |
| EG001 | Aflibercept 2 mg Q8W | Participants randomized to this arm received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 8, followed by 2 mg aflibercept IVT injections Q8W to Week 52 | 8 | 280 | 33 | 280 | 84 | 280 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Endophthalmitis - Study eye | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Retinal haemorrhage - Study eye | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Neovascular age-related macular degeneration - Study eye | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Rhegmatogenous retinal detachment - Study eye | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Ilium fracture | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Intestinal dilatation | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Perforated ulcer | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Transient aphasia | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Benign gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Systematic Assessment |
| |
| Colon cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA version 23.1 | Systematic Assessment |
| |
| Prostatic varices | Reproductive system and breast disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA version 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neovascular age-related macular degeneration - Fellow eye | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Retinal haemorrhage - Study eye | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Cataract - Study eye | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage - Study eye | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 23.1 | Systematic Assessment |
|
This study was terminated early by the Sponsor because the study did not meet the primary endpoint. Thus, not all participants in this study completed the full duration of treatment.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pablo Velazquez-Martin, MD | Kodiak Sciences Inc. | 1 (650) 281-0850 | ClinOps@kodiak.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2022 | Apr 4, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D014786 | Vision Disorders |
| D015354 | Vision, Low |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Europe |
|
|
Drug: Aflibercept 2 mg. Aflibercept 2 mg will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks. Drug: Sham Procedure. The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. Aflibercept: Intravitreal Injection Sham Procedure: The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. |
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| Participants |
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| Participants |
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