Wet Age-related Macular Degeneration Clinical Trial
— DAYLIGHTOfficial title:
A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
Verified date | May 2023 |
Source | Kodiak Sciences Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)
Status | Completed |
Enrollment | 557 |
Est. completion date | April 6, 2023 |
Est. primary completion date | March 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent prior to participation in the study. - Treatment-naïve choroidal neovascularization (CNV) secondary to AMD. - BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye. - Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD. - Other protocol-specified inclusion criteria may apply Exclusion Criteria: - BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular). - Active or suspected ocular or periocular infection or inflammation. - CNV secondary to other causes in the Study Eye. - Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study. - Uncontrolled glaucoma in the Study Eye. - Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography. - Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening. - Women who are pregnant or lactating or intending to become pregnant during the study. - Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event. - History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product. - Uncontrolled blood pressure defined as a systolic value =180 mmHg or diastolic value =100 mmHg while at rest. - Other protocol-specified exclusion criteria may apply |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Emanuelli Research & Development Center LLC | Arecibo | |
United States | Retina Research Institute of Texas | Abilene | Texas |
United States | Western Carolina Retinal Associate PA | Asheville | North Carolina |
United States | Southeast Retina Center | Augusta | Georgia |
United States | Austin Retina Associates | Austin | Texas |
United States | California Retina Consultants | Bakersfield | California |
United States | Retina Research of Beaufort | Beaufort | South Carolina |
United States | The Retina Center of New Jersey | Bloomfield | New Jersey |
United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
United States | Florida Eye Microsurgical Institute | Boynton Beach | Florida |
United States | Retina Group of Washington | Chevy Chase | Maryland |
United States | University of Chicago | Chicago | Illinois |
United States | Cleveland Clinic Foundation, Cole Eye Institute | Cleveland | Ohio |
United States | Retina Associates of Cleveland | Cleveland | Ohio |
United States | Rand Eye Institute | Deerfield Beach | Florida |
United States | Vitreoretinal Surgery PA | Edina | Minnesota |
United States | Talley Eye | Evansville | Indiana |
United States | National Ophthalmic Research Institute | Fort Myers | Florida |
United States | Retina Health Center | Fort Myers | Florida |
United States | Eye Medical Center of Fresno | Fresno | California |
United States | Retina Consultants of Orange County | Fullerton | California |
United States | Foundation for Vision Research | Grand Rapids | Michigan |
United States | Cumberland Valley Retina Consultants PC | Hagerstown | Maryland |
United States | Retina Consultants of Texas | Houston | Texas |
United States | Retina Consultants of Texas-(Katy) | Katy | Texas |
United States | Southeastern Retina Associates PC | Knoxville | Tennessee |
United States | UCSD Jacobs Retina Center | La Jolla | California |
United States | Charleston Neuroscience Institute | Ladson | South Carolina |
United States | Retina Associates of Orange County | Laguna Hills | California |
United States | Colorado Retina Associates PC | Lakewood | Colorado |
United States | Retina Associates PA | Lenexa | Kansas |
United States | Retina Associates of Kentucky | Lexington | Kentucky |
United States | Retina-Vitreous Surgeons of Central NY | Liverpool | New York |
United States | Florida Eye Associates | Melbourne | Florida |
United States | Northern California Retina Vitreous Associates | Mountain View | California |
United States | Tennessee Retina PC | Nashville | Tennessee |
United States | Retina Specialty Institute | Pensacola | Florida |
United States | MidAtlantic Retina | Philadelphia | Pennsylvania |
United States | Retinal Research Institute, LLC | Phoenix | Arizona |
United States | Texas Retina Associates | Plano | Texas |
United States | Retina Northwest | Portland | Oregon |
United States | Retina Consultants of San Diego | Poway | California |
United States | Black Hills Regional Eye Institute | Rapid City | South Dakota |
United States | Retina Consultants of Southern California | Redlands | California |
United States | Sierra Eye Associates | Reno | Nevada |
United States | Retina Associates of Western NY | Rochester | New York |
United States | Austin Retina Associates (Round Rock) | Round Rock | Texas |
United States | Associated Retinal Consultants PC | Royal Oak | Michigan |
United States | Retinal Consultants Medical Group Inc | Sacramento | California |
United States | Retina Vitreous Associates of Florida | Saint Petersburg | Florida |
United States | Retina Consultants, LLC | Salem | Oregon |
United States | Medical Center Ophthalmology Associates | San Antonio | Texas |
United States | Orange County Retina Medical Group | Santa Ana | California |
United States | Spokane Eye | Spokane | Washington |
United States | Northwest Arkansas Retina Associates | Springdale | Arkansas |
United States | Cascade Medical Research Institute | Springfield | Oregon |
United States | New England Retina Consultants | Springfield | Massachusetts |
United States | Springfield Clinic LLP | Springfield | Illinois |
United States | Retina Associates of Florida | Tampa | Florida |
United States | NJ Retina | Teaneck | New Jersey |
United States | Retina Consultants of Texas - (Woodlands) | The Woodlands | Texas |
United States | Retina Group of New England | Waterford | Connecticut |
United States | Palmetto Retina Center | West Columbia | South Carolina |
United States | Wolfe Eye Clinic | West Des Moines | Iowa |
United States | Strategic Clinical Research Group, LLC | Willow Park | Texas |
United States | Vitreo Retinal Associates PC | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Kodiak Sciences Inc |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48. | 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. | Day 1 to Week 48 | |
Secondary | Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time | 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. | Day 1 to Week 48 | |
Secondary | Proportion of Patients Who Gain = 5, =10 and =15 Letters From Baseline Over Time | 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 | Day 1 to Week 48 | |
Secondary | Proportion of Patients Who Lost = 5, =10 and =15 Letters From Baseline Over Time | Categorical worsening in Best Corrected Visual Acuity (BCVA) of clinically relevant BCVA measurements corresponding to 1, 2 and 3 lines of the ETDRS vision testing chart | Day 1 to Week 48 | |
Secondary | Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (=69 ETDRS Letters) | 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. | Day 1 to Week 48 | |
Secondary | Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (=38 ETDRS Letters) | 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. | Day 1 to Week 48 | |
Secondary | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time | 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. | Day 1 to Week 48 |
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