Trials
Search / Trial NCT05642325

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.

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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