Vamikibart in Participants With Uveitic Macular Edema
Launched by HOFFMANN-LA ROCHE · Dec 6, 2022
Trial Information
Current as of January 17, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called vamikibart to see if it is effective and safe for people with uveitic macular edema, a condition that causes swelling in the eye and can affect vision due to inflammation. The trial is currently looking for volunteers aged 65 to 74, and both men and women are welcome to participate. To qualify, participants must have a specific type of eye condition related to non-infectious uveitis and meet certain vision criteria.
If you decide to join the study, you will be closely monitored to track your health and any changes in your vision. There are some important requirements to keep in mind: participants should not have certain infections or serious health issues, and there are restrictions on previous treatments. This trial aims to provide valuable information about a new treatment option for people dealing with this challenging eye condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol
- • Diagnosis of macular edema associated with non-infectious uveitis (NIU)
- • Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis)
- • BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts
- Exclusion Criteria:
- • Evidence of active or latent syphilis infection
- • Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis
- • Serious acute or chronic medical or psychiatric illness
- • History of major ocular and non-ocular surgical procedures
- • Uncontrolled IOP or glaucoma or chronic hypotony
- • Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images
- • Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1
- • Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1
- • Topical corticosteroids and/or topical NSAID \> 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1
- • Diagnosis of macular edema due to any cause other than NIU
- • Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
Trial Officials
Clinical Trials
Study Director
Hoffmann-LaRoche
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Little Rock, Arkansas, United States
Zaragoza, , Spain
Paris, , France
Morgantown, West Virginia, United States
Madison, Wisconsin, United States
Singapore, , Singapore
Singapore, , Singapore
Hamburg, , Germany
Madrid, , Spain
Fairfax, Virginia, United States
Birmingham, , United Kingdom
Middlesborough, , United Kingdom
Paris, , France
Chevy Chase, Maryland, United States
Hiroshima, , Japan
Fukuoka, , Japan
Barcelona, , Spain
Barakaldo, Vizcaya, Spain
Bristol, , United Kingdom
Liverpool, , United Kingdom
Gloucester, , United Kingdom
Madurai, Tamil Nadu, India
Phoenix, Arizona, United States
Singapore, , Singapore
Seoul, , Korea, Republic Of
Durham, North Carolina, United States
Ankara, , Turkey
Busan, , Korea, Republic Of
Mountain View, California, United States
Seoul, , Korea, Republic Of
Abilene, Texas, United States
Tokyo, , Japan
Osaka, , Japan
London, , United Kingdom
Hyogo, , Japan
Lisboa, , Portugal
Heidelberg, , Germany
Munster, , Germany
Taipei, , Taiwan
Chandigarh, , India
Köln, , Germany
Wuhan, , China
Hokkaido, , Japan
Milano, Lombardia, Italy
Philadelphia, Pennsylvania, United States
Beijing, , China
Seoul, , Korea, Republic Of
Riverside, California, United States
Tokyo, , Japan
Nashville, Tennessee, United States
East Melbourne, Victoria, Australia
Busan, , Korea, Republic Of
Mesa, Arizona, United States
Chongqing, , China
Fullerton, California, United States
Ann Arbor, Michigan, United States
Fort Lauderdale, Florida, United States
Sydney, New South Wales, Australia
Marseille, , France
Redlands, California, United States
Ankara, , Turkey
Durham, North Carolina, United States
Oak Forest, Illinois, United States
Royal Oak, Michigan, United States
Paris, , France
Paris, , France
Bonn, , Germany
Göttingen, , Germany
Köln, , Germany
Lübeck, , Germany
Hospitalet De Llobregat, Barcelona, Spain
Sacramento, California, United States
Nedlands, Western Australia, Australia
Lyon Cedex, , France
Marseille, , France
Freiburg, , Germany
Heidelberg, , Germany
Coimbra, , Portugal
Ankara, , Turkey
Ankara, , Turkey
Osaka, , Japan
Kanagawa, , Japan
Tokyo, , Japan
Mount Pleasant, South Carolina, United States
Sacramento, California, United States
Bellaire, Texas, United States
Kagoshima, , Japan
Göttingen, , Germany
Nantes, , France
Beijing City, , China
Yamaguchi, , Japan
Saitama, , Japan
Lzmir, , Turkey
Nantes, , France
Malvern, Victoria, Australia
Hyderabad, Telangana, India
Pasadena, California, United States
Redlands, California, United States
Hagerstown, Maryland, United States
Saitama, , Japan
Konya, , Turkey
Rowville, Victoria, Australia
Tianjin City, , China
Singapore, , Singapore
Singapore, , Singapore
Madrid, , Spain
Binningen, , Switzerland
Tübingen, , Germany
Chennai, Tamil Nadu, India
London, , United Kingdom
Sun City, Arizona, United States
Zürich, , Switzerland
Ciudad Autonoma Buenos Aires, , Argentina
Zaragoza, , Spain
Istanbul, , Turkey
Madrid, , Spain
Bern, , Switzerland
Coral Springs, Florida, United States
Prague, , Czechia
Milano, , Italy
Katy, Texas, United States
Cherry Hill, New Jersey, United States
San Nicolás, , Argentina
Sulzbach, , Germany
The Woodlands, Texas, United States
Fullerton, California, United States
Cleveland, Ohio, United States
Katy, Texas, United States
Madison, Wisconsin, United States
Rosario, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Hyogo, , Japan
Lausanne, , Switzerland
Bern, , Switzerland
Berlin, , Germany
Tokyo, , Japan
Madrid, , Spain
Dessau, , Germany
Barcelona, , Spain
Paris, , France
Barakaldo, Vizcaya, Spain
Gaz?Osmanpa?A, , Turkey
Brno, , Czechia
Hamburg, , Germany
Bangalore, Karnataka, India
Erie, Pennsylvania, United States
Deerfield Beach, Florida, United States
Noida, Uttar Pradesh, India
Almaty, , Kazakhstan
Tokyo, , Japan
Reggio Emilia, Emilia Romagna, Italy
Taoyuan, , Taiwan
Maidstone, Kent, , United Kingdom
Rosario, , Argentina
Brno, , Czechia
Prague, , Czechia
Lyon Cedex, , France
Paris, , France
Berlin, , Germany
Lübeck, , Germany
Sulzbach, , Germany
Saitama, , Japan
Hospitalet De Llobregat, Barcelona, Spain
Bern, , Switzerland
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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