A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)
Launched by BAYER · Apr 28, 2023
Trial Information
Current as of April 24, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for people who have vision problems due to swelling in the macula, which is the center part of the retina, caused by a blocked vein in the eye. This condition is known as macular edema secondary to retinal vein occlusion (RVO). The researchers are testing whether a higher dose of aflibercept, an injection already used to treat this condition, can work better and be given less frequently than the standard dose. Participants will have their vision measured over the course of 36 weeks to see how well the treatment improves their eyesight and to ensure it is safe.
To be eligible for this trial, participants must be adults aged 18 and older with a specific level of vision loss due to RVO diagnosed within the last 16 weeks. They should not have other serious eye conditions or health issues that could interfere with the study. Throughout the study, participants will have regular check-ups, including eye exams and health assessments, and will be asked to complete a questionnaire about their vision-related quality of life. The trial will last up to 64 weeks, involving a series of visits to the study site for monitoring and treatment.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult ≥18 years of age (or country's legal age of adulthood if the legal age is \>18 years) at the time of signing the informed consent.
- • Treatment-naïve macular edema involving the foveal center secondary to RVO (BRVO, HRVO, or CRVO) diagnosed within 16 weeks (112 days) before the screening visit in the study eye.
- • Early Treatment Diabetic Retinopathy Study BCVA letter score of 73 to 24 (20/40 to 20/320) at screening and baseline visits in the study eye.
- • Decrease in BCVA determined to be primarily the result of RVO in the study eye.
- • Mean CST ≥300 μm on optical coherence tomography (OCT) if excluding Bruch's membrane (e.g., Cirrus or Topcon) or ≥320 μm if including Bruch's membrane (e.g., Heidelberg Spectralis), confirmed by the reading center at the screening visit and by the site at baseline visit in the study eye.
- • Capable of giving signed informed consent form (ICF) by study participant or legally acceptable representative, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- • US participants will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws.
- • Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for participation in clinical studies and fulfil the conditions set on Section 10.4.2.
- Exclusion Criteria:
- • Concurrent disease that causes substantial decrease of BCVA, is expected to limit BCVA recovery or is likely to require medical or surgical intervention during the study in the study eye.
- * Presence or history of the following ocular conditions:
- • 1. Advanced age-related macular degeneration (neovascular AMD or geographic atrophy) in the study eye.
- • 2. Diabetic macular edema or diabetic retinopathy, defined in diabetic participants as diabetic retinopathy lesions outside the area of the vein occlusion in the study eye and anywhere in the retina in the fellow eye.
- • 3. Anterior segment neovascularization, vitreous hemorrhage, retinal detachment in the study eye.
- • 4. Vitreomacular traction, epiretinal membrane or structural damage to the macula that is considered by the Investigator to significantly affect central vision or preclude improvement in vision in the study eye.
- • 5. Macular hole of stage 2 and above in the study eye.
- • 6. Myopia of a spherical equivalent of at least 8 diopters prior to any refractive or cataract surgery in the study eye.
- • 7. Corneal transplant or corneal dystrophy in the study eye.
- • 8. Idiopathic or autoimmune uveitis in the study or in the fellow eye.
- * Presence of the following ocular conditions at screening or baseline visit:
- • 1. Significant media opacities, including cataract, that interfere with BCVA, or imaging assessments (e.g., fundus photography \[FP\], OCT) in the study eye.
- • 2. Aphakia, or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium-aluminum-garnet \[YAG\] posterior capsulotomy performed more than 30 days before the screening visit), in the study eye.
- • 3. Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with anti-glaucoma medication); or history or likely future need of glaucoma surgery in the study eye.
- • 4. Intraocular inflammation/infection (including trace, or above, cells in the anterior chamber and/or vitreous) within 12 weeks (84 days) of the screening visit in the study or in the fellow eye.
- • 5. Extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in the study or in the fellow eye.
- • Uncontrolled blood pressure (defined as systolic \>160 mmHg or diastolic \>95 mmHg) at the screening visit or baseline visit.
- • Uncontrolled diabetes mellitus, defined by hemoglobin A1c (HbA1c) \>12% at the screening visit.
- • History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) before the screening visit or between screening and baseline visits.
- • Renal failure requiring dialysis, or renal transplant at screening or potentially during the study.
- • Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for RVO in the study eye.
- • Previous administration of systemic anti-angiogenic medications for any condition.
- * Prior treatment of the study eye with any of the following drugs (any route of ophthalmic administration) or procedures:
- • 1. Anti-angiogenic drugs at any time including investigational therapy (e.g., with anti-angiopoietin/anti-VEGF bispecific monoclonal antibodies).
- • 2. Previous use topical steroids within 4 weeks (28 days) from the screening visit, or intraocular or periocular steroids within 16 weeks (112 days) from the screening visit, or steroid implants at any time.
- • 3. Previous treatment with intraocular or periocular implant, gene therapy, or cell therapy at any time.
- • 4. Treatment with ocriplasmin at any time.
- • 5. Vitreoretinal surgery (including scleral buckling) at any time.
- • 6. Any intraocular surgery, including cataract surgery, within 12 weeks (84 days) before the screening visit.
- • 7. Previous treatment with retinal laser photocoagulation.
- * Prior treatment of the fellow eye with any of the following:
- • a. Gene therapy, or cell therapy in the fellow eye at any time.
- • Participation in other clinical studies requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening visit, or within 30 days or 5 half-lives of administration of the previous study intervention, whichever is longer.
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampa, Florida, United States
Philadelphia, Pennsylvania, United States
Chicago, Illinois, United States
Stanford, California, United States
Zaragoza, , Spain
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Charleston, South Carolina, United States
Austin, Texas, United States
Valencia, , Spain
Riverside, California, United States
Khon Kaen, , Thailand
Córdoba, , Spain
Leicester, Leicestershire, United Kingdom
Okayama, , Japan
Fukushima, , Japan
Fort Myers, Florida, United States
Stuart, Florida, United States
Winter Haven, Florida, United States
Hagerstown, Maryland, United States
Beijing, , China
Liverpool, , United Kingdom
Palm Springs, California, United States
Cincinnati, Ohio, United States
Otsu, Shiga, Japan
Bradford, , United Kingdom
Beijing, , China
Yamagata, , Japan
Toyama, , Japan
Bradford, West Yorkshire, United Kingdom
Wolverhampton, , United Kingdom
Shinjuku Ku, Tokyo, Japan
Kurume, Fukuoka, Japan
Kobe, Hyogo, Japan
Hachioji, Tokyo, Japan
Akita, , Japan
Tsu, Mie, Japan
Freiburg, Baden Württemberg, Germany
Nitra, , Slovakia
Madison, Wisconsin, United States
Lynbrook, New York, United States
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bunkyo Ku, Tokyo, Japan
Praha 10, , Czechia
Yokohama, Kanagawa, Japan
Tallinn, , Estonia
London, , United Kingdom
Jinan, Shandong, China
Shinjuku Ku, Tokyo, Japan
Great Neck, New York, United States
San Antonio, Texas, United States
Pensacola, Florida, United States
Beijing, Beijing, China
Milano, , Italy
Seoul, , Korea, Republic Of
Nitra, , Slovakia
Tartu, , Estonia
Banska Bystrica, , Slovakia
Sakura, Chiba, Japan
Trencin, , Slovakia
Largo, Florida, United States
Winston Salem, North Carolina, United States
Belgrade, , Serbia
Nagoya, Aichi, Japan
Meguro Ku, Tokyo, Japan
Ankara, , Turkey
Ankara, , Turkey
Graz, Steiermark, Austria
Fukuoka, , Japan
Coimbra, , Portugal
Chuo, Yamanashi, Japan
Belgrade, , Serbia
Hradec Kralove, , Czechia
Beijing, , China
Tartu, , Estonia
Seoul, , Korea, Republic Of
Xi'an, Shaanxi, China
Ube, Yamaguchi, Japan
Ostrava, , Czechia
West Columbia, South Carolina, United States
Lyon, , France
Gyeonggi Do, , Korea, Republic Of
Ostrava, , Czechia
Spokane, Washington, United States
Poprad, , Slovakia
Hauppauge, New York, United States
Philadelphia, Pennsylvania, United States
Rehovot, , Israel
Seoul, , Korea, Republic Of
Sant Cugat Del Valles, Barcelona, Spain
Istanbul, , Turkey
London, , United Kingdom
Plantation, Florida, United States
Nagakute, Aichi, Japan
Debrecen, , Hungary
Nedlands, Western Australia, Australia
Kfar Saba, , Israel
Maebashi, Gunma, Japan
Melbourne, Florida, United States
Reno, Nevada, United States
Busan, , Korea, Republic Of
Budapest, , Hungary
Tel Aviv, , Israel
New London, Connecticut, United States
Hangzhou, Zhejiang, China
Coventry, West Midlands, United Kingdom
Coventry, , United Kingdom
Fullerton, California, United States
Barcelona, , Spain
Matsumoto, Nagano, Japan
Sofia, , Bulgaria
Daegu, , Korea, Republic Of
Rochester, New York, United States
Sydney, New South Wales, Australia
Chengdu, Sichuan, China
Adelaide, South Australia, Australia
Kita Gun, Kagawa, Japan
Rehovot, , Israel
Long Beach, California, United States
Marietta, Georgia, United States
Oak Forest, Illinois, United States
Lyon Cedex 04, , France
Las Vegas, Nevada, United States
New Brunswick, New Jersey, United States
Novi Sad, , Serbia
Wolverhampton, West Midlands, United Kingdom
Colorado Springs, Colorado, United States
Roma, Lazio, Italy
Roma, Lazio, Italy
Kocaeli, , Turkey
Hefei, Anhui, China
Hefei, Anhui, China
Ankara, , Turkey
Bloomfield, New Jersey, United States
Albury, New South Wales, Australia
Bydgoszcz, , Poland
Izmir, , Turkey
Binningen, , Switzerland
Vilnius, , Lithuania
Praha 2, , Czechia
Bratislava, , Slovakia
Bratislava, , Slovakia
Milano, Lombardia, Italy
Chofu, Tokyo, Japan
Strathfield, New South Wales, Australia
Holon, , Israel
Bern, , Switzerland
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Tianjin, , China
Milano, Lombardia, Italy
Leeds, West Yorkshire, United Kingdom
Budapest, , Hungary
Porto, , Portugal
Beer Sheva, , Israel
Tokorozawa, Saitama, Japan
Kagoshima, , Japan
Seongnam Si, Gyeonggido, Korea, Republic Of
Haifa, , Israel
Jerusalem, , Israel
Ancona, Marche, Italy
Osaka, , Japan
Majadahonda, Madrid, Spain
Ankara, , Turkey
Orlando, Florida, United States
Hagerstown, Maryland, United States
Praha 2, , Czechia
Yoshida, Fukui, Japan
Pamplona, , Spain
Saitama, , Japan
Xuzhou, Jiangsu, China
Chiangmai, , Thailand
Tianjin, , China
Fort Worth, Texas, United States
Sofia, , Bulgaria
Olsztyn, , Poland
Sofia, , Bulgaria
Amagasaki, Hyogo, Japan
Klagenfurt, Kärnten, Austria
Torino, Piemonte, Italy
Shanghai, , China
Beijing, , China
Adana, , Turkey
Ankara, , Turkey
Deerfield Beach, Florida, United States
Haifa, , Israel
Wien, , Austria
Seongnam Si, Gyeonggido, Korea, Republic Of
Seoul, Other, Korea, Republic Of
Wien, , Austria
Wuhan, Hubei, China
Budapest, , Hungary
Budapest, , Hungary
Miyazaki, , Japan
Petah Tikva, , Israel
Zerifin, , Israel
Bethlehem, Pennsylvania, United States
Shenyang, , China
Memphis, Tennessee, United States
Sofia, , Bulgaria
Rochester, New York, United States
Nagasaki, , Japan
Bellaire, Texas, United States
Hobart, Tasmania, Australia
Praha 5, , Czechia
Linz, , Austria
Ankara, , Turkey
Praha 5, , Czechia
Varna, , Bulgaria
Chiyoda Ku, Tokyo, Japan
Riga, , Latvia
Barcelona, , Spain
Elmhurst, Illinois, United States
Krakow, , Poland
Linz, Oberösterreich, Austria
Pardubice, , Czechia
Paris, , France
Porto, , Portugal
Troy, New York, United States
Mountain View, California, United States
Pasadena, California, United States
Saint Petersburg, Florida, United States
Baltimore, Maryland, United States
Albuquerque, New Mexico, United States
Dublin, Ohio, United States
Salem, Oregon, United States
Sydney, New South Wales, Australia
Sofia, , Bulgaria
Guangzhou, Guangdong, China
Shijiazhuang, Hebei, China
Xingtai, Hebei, China
Zhengzhou, Henan, China
Changchun, Jilin, China
Yinchuan, Ningxia, China
Chengdu, Sichuan, China
Wenzhou, Zhejiang, China
Beijing, , China
Chongqing, , China
Tianjin, , China
Praha 4, , Czechia
Marseille, , France
Tbilisi, , Georgia
Tel Aviv, , Israel
Roma, Lazio, Italy
Milano, Lombardia, Italy
Koriyama, Fukushima, Japan
Mito, Ibaraki, Japan
Itabashi Ku, Tokyo, Japan
Wakayama, , Japan
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Coimbra, , Portugal
Santiago De Compostela, A Coruña, Spain
Lausanne, Vaud, Switzerland
Bern, , Switzerland
Budapest, , Hungary
Aydin, , Turkey
Szeged, , Hungary
Kawasaki, Kanagawa, Japan
Dijon, , France
Florence, South Carolina, United States
Pecs, , Hungary
Krakow, , Poland
Rzeszow, , Poland
Sant Cugat Del Vallés, Barcelona, Spain
Lausanne, , Switzerland
Sunderland, Tyne And Wear, United Kingdom
Wuhan, Hubei, China
Pasadena, California, United States
Bratislava, , Slovakia
San Antonio, Texas, United States
San Antonio, Texas, United States
Nishinomiya, Hyogo, Japan
Bordeaux, , France
Tours, , France
Beijing, , China
Budapest, , Hungary
Great Neck, New York, United States
Kawasaki, Kanagawa, Japan
Bari, Puglia, Italy
Itabashi Ku, Tokyo, Japan
Barcelona, , Spain
Ankara, , Turkey
Loma Linda, California, United States
Largo, Florida, United States
Lenexa, Kansas, United States
Grand Rapids, Michigan, United States
Saint Louis Park, Minnesota, United States
Teaneck, New Jersey, United States
Chapel Hill, North Carolina, United States
Bellaire, Texas, United States
Salt Lake City, Utah, United States
Virginia Beach, Virginia, United States
Parramatta, New South Wales, Australia
Westmead, New South Wales, Australia
East Melbourne, Victoria, Australia
Shenyang, Liaoning, China
Shenyang, Liaoning, China
Taiyuan, Shaanxi, China
Jinhua, Zhejiang, China
Beijing, , China
Chongqing, , China
Chongqing, , China
Hangzhou, , China
Lanzhou, , China
Pardubice, , Czechia
Praha 2, , Czechia
Tallinn, , Estonia
Tallinn, , Estonia
Paris, Cedex 12, France
Bordeaux, , France
Creteil Cedex, , France
Nantes, , France
Paris, , France
Paris, , France
Paris, , France
Strasbourg, , France
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Budapest, , Hungary
Jerusalem, , Israel
Narita, Chiba, Japan
Toride, Ibaraki, Japan
Fujieda, Shizuoka, Japan
Chofu, Tokyo, Japan
Fukuoka, , Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Bandar Puncak Alam, , Malaysia
Kuala Lumpur, , Malaysia
Shah Alam, , Malaysia
Shah Alam, , Malaysia
Mexico D. F., Distrito Federal, Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Queretaro, , Mexico
Queretaro, , Mexico
Bydgoszcz, , Poland
Gdansk, , Poland
Gdansk, , Poland
Katowice, , Poland
Walbrzych, , Poland
Vila Nova De Gaia, Porto, Portugal
Lisboa, , Portugal
Zvolen, , Slovakia
Barcelona, , Spain
Valladolid, , Spain
Ankara, , Turkey
Istanbul, , Turkey
Colchester, Essex, United Kingdom
Barnet, Hertfordshire, United Kingdom
Great Yarmouth, Norfolk, United Kingdom
Camberley, Surrey, United Kingdom
Epsom, Surrey, United Kingdom
Hull, York, United Kingdom
Tbilisi, , Georgia
Pathum Thani,, , Thailand
Ankara, , Turkey
Liverpool, , United Kingdom
York, , United Kingdom
Hagerstown, Maryland, United States
Sunderland, Tyne And Wear, United Kingdom
Albuquerque, New Mexico, United States
Salem, Oregon, United States
Chongqing, , China
Toride, Ibaraki, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Mexico City, Distrito Federal, Mexico
Adana, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Aydin, , Turkey
London Borough Of Barnet, Hertfordshire, United Kingdom
Great Yarmouth, Norfolk, United Kingdom
Frimley, Surrey, United Kingdom
Coventry, West Midlands, United Kingdom
Wolverhampton, West Midlands, United Kingdom
Hull, York, United Kingdom
York, , United Kingdom
Sulzbach, Saarland, Germany
Bonn, , Germany
Düsseldorf, , Germany
Göttingen, , Germany
Hannover, , Germany
Heidelberg, , Germany
Jena, , Germany
Ludwigshafen, , Germany
Marburg, , Germany
Muenster, , Germany
Munich, , Germany
Tuebingen, , Germany
Budapest, , Hungary
Walbrzych, , Poland
Stuart, Florida, United States
Hagerstown, Maryland, United States
Tbilisi, , Georgia
Hauppauge, New York, United States
Ankara, , Turkey
Ankara, , Turkey
Bilkent çankaya, , Turkey
Ankara, , Turkey
Chicago, Illinois, United States
Mexico City, , Mexico
Jinan, Shandong, China
Sofia, , Bulgaria
Shijiazhuang, Hebei, China
Budapest, , Hungary
Seoul, , Korea, Republic Of
Bern, , Switzerland
Adana, , Turkey
Beijing, , China
Beijing, , China
Hagerstown, Maryland, United States
Beer Sheva, , Israel
Holon, , Israel
Petah Tikva, , Israel
Koriyama, Tokyo, Japan
Petach Tikva, , Israel
Hebei, Hebei, China
Henan, Henan, China
Ningxia, Ningxia, China
Roma, Lazio, Italy
Milano, Lombardia, Italy
Porto, , Portugal
Jinan, Shandong, China
Porto, , Portugal
Shah Alam, Selangor, Malaysia
Roma, Lazio, Italy
Hagerstown, Maryland, United States
Palm Springs, California, United States
Chapel Hill, North Carolina, United States
Salt Lake City, Utah, United States
Nedlands, Western Australia, Australia
Sofia, , Bulgaria
Shenyang, Liaoning, China
Shanxi, Shaanxi, China
Praha 10, , Czechia
Chiyoda Ku, Tkyo, Japan
Bandar Puncak Alam, Selangor, Malaysia
Shah Alam, Selangor, Malaysia
Bratislava, , Slovakia
Zvolen, , Slovakia
Austin, Texas, United States
New London, Connecticut, United States
Winter Haven, Florida, United States
Bloomfield, New Jersey, United States
Blue Ash, Ohio, United States
Fairfax, Virginia, United States
Roma, Lazio, Italy
Fujieda Shi, Shizuoka, Japan
Orlando, Florida, United States
Memphis, Tennessee, United States
Varna, , Bulgaria
Bilkent Ankara, , Turkey
Jinan, Shandong, China
Holon, , Israel
Shenyang, Liaoning, China
Pasadena, California, United States
Hradec Kralove, , Czechia
Leeds, West Yorkshire, United Kingdom
Paris, , France
Melbourne, Florida, United States
Albuquerque, New Mexico, United States
Roma, Lazio, Italy
Hauppauge, New York, United States
Philadelphia, Pennsylvania, United States
Tallinn, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Dijon, , France
Torrette, Ancona, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Related Blog Entries
View all
