Clinical Trials
Benobio
A Phase 1, Open Label, Dose Escalation Study to Evaluate the Safety of BBC1501 Intravitreal Injection for Neovascular Age-Related Macular Degeneration.
Overview
This research project is investigating a new treatment for neovascular age-related macular degeneration (nAMD) called BBC1501. BBC1501 is a small molecule drug, which may be another treatment option for people with nAMD who don’t respond to current available treatments. It is administered by injection into the eye (called intravitreal injection).
nAMD is a prevalent, progressive retinal eye disease that is characterised by neovascularization, which is the formation of new blood vessels in the choroid (a layer of tissue in the eye that is filled with blood vessels). Leaking of fluid from these new blood vessels in the eye may result in loss of vision.
BBC1501 is expected to work by blocking a protein called bromodomain-containing protein 2 (BRD2) which is present when neovascularization takes place. BBC1501 may reduce the formation of new blood vessels and reduce the inflammation and damage seen with nAMD.
The purpose of this research study is to see if BBC1501 is a safe and effective treatment for patients with nAMD. BBC1501 has not been tested in humans before. This is the first time BBC1501 will be tested in humans. It is not known what side effects might occur, and it is not known whether BBC1501 will have any effect on nAMD.
This study will enrol up to 18 participants in 3 groups (cohorts). Suitable participants will be screened to determine their eligibility for the trial and those eligible will receive only a one-time administration of the study drug. This is a dose escalation study, which means the first group will receive the lowest dose of the study drug. If the lowest dose is considered to be safe after the review of all safety data by the Safety Monitoring Committee, the next group will receive a higher dose. The study is open label, meaning that you and the study staff will know what dose of study drug you will receive.
The study duration is 14 weeks, with participation involving up to 7 visits at our site.
For further information please contact Cerulea on 99298076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator
Dr Amy Cohn
This research project is investigating a new treatment for neovascular age-related macular degeneration (nAMD) called BBC1501. BBC1501 is a small molecule drug, which may be another treatment option for people with nAMD who don’t respond to current available treatments. It is administered by injection into the eye (called intravitreal injection).
nAMD is a prevalent, progressive retinal eye disease that is characterised by neovascularization, which is the formation of new blood vessels in the choroid (a layer of tissue in the eye that is filled with blood vessels). Leaking of fluid from these new blood vessels in the eye may result in loss of vision.
BBC1501 is expected to work by blocking a protein called bromodomain-containing protein 2 (BRD2) which is present when neovascularization takes place. BBC1501 may reduce the formation of new blood vessels and reduce the inflammation and damage seen with nAMD.
The purpose of this research study is to see if BBC1501 is a safe and effective treatment for patients with nAMD. BBC1501 has not been tested in humans before. This is the first time BBC1501 will be tested in humans. It is not known what side effects might occur, and it is not known whether BBC1501 will have any effect on nAMD.
This study will enrol up to 18 participants in 3 groups (cohorts). Suitable participants will be screened to determine their eligibility for the trial and those eligible will receive only a one-time administration of the study drug. This is a dose escalation study, which means the first group will receive the lowest dose of the study drug. If the lowest dose is considered to be safe after the review of all safety data by the Safety Monitoring Committee, the next group will receive a higher dose. The study is open label, meaning that you and the study staff will know what dose of study drug you will receive.
The study duration is 14 weeks, with participation involving up to 7 visits at our site.
For further information please contact Cerulea on 99298076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator