Clinical Trials
ABACUS-2
A phase II, randomised, controlled, double masked, multiple dose study of the safety, tolerability and efficacy of intravitreal KIO-301 in patients with late-stage retinitis pigmentosa
Overview
This research project is testing a new treatment for RP.
The new treatment is called KIO-301. Retinitis pigmentosa, or RP, is an inherited eye condition, which progressively worsens over time.
RP causes damage to the light-sensing cells at the back of the eye.
These are located in the retina, a thin layer of tissue at the back of the eye.
Normally, these cells detect light and send electrical signals to other cells in the retina and the brain.
Some of these cells are called retinal ganglion cells (RGCs).
Currently there is no effective treatment for people with RP.
We want to see if KIO-301 is safe and improves vision when it is given as an injection into each eye.
KIO-301 works by improving the ability of the RGCs to become activated by light and send electrical signals to the brain.
It is believed that by increasing the amount of signal reaching the brain, it may lead to an improvement in vision.
KIO-301 has been investigated in a previous (first) clinical study called ABACUS.
This current study, called ABACUS-2, is the second clinical study and has been designed to check if KIO-301 has any effect on vision when compared to a placebo, which is the same as no treatment.
Treatment allocation to placebo (saline injection) or to the treatment (KIO-301) will be done in a random fashion; you are unable to choose which one you will receive.
Overall, you will have a 66% chance of receiving the KIO-301 injections, and a 33% chance of receiving the placebo injections.
A total of 3 injections will be received throughout the 7 month duration of the study.
For further information about this study please contact the Clinical Trials Research Centre on (03) 9929 8076 or email info@ceruleaclinicaltrials.org.au
- Principal Investigator
Dr Doron Hickey
This research project is testing a new treatment for RP.
The new treatment is called KIO-301. Retinitis pigmentosa, or RP, is an inherited eye condition, which progressively worsens over time.
RP causes damage to the light-sensing cells at the back of the eye.
These are located in the retina, a thin layer of tissue at the back of the eye.
Normally, these cells detect light and send electrical signals to other cells in the retina and the brain.
Some of these cells are called retinal ganglion cells (RGCs).
Currently there is no effective treatment for people with RP.
We want to see if KIO-301 is safe and improves vision when it is given as an injection into each eye.
KIO-301 works by improving the ability of the RGCs to become activated by light and send electrical signals to the brain.
It is believed that by increasing the amount of signal reaching the brain, it may lead to an improvement in vision.
KIO-301 has been investigated in a previous (first) clinical study called ABACUS.
This current study, called ABACUS-2, is the second clinical study and has been designed to check if KIO-301 has any effect on vision when compared to a placebo, which is the same as no treatment.
Treatment allocation to placebo (saline injection) or to the treatment (KIO-301) will be done in a random fashion; you are unable to choose which one you will receive.
Overall, you will have a 66% chance of receiving the KIO-301 injections, and a 33% chance of receiving the placebo injections.
A total of 3 injections will be received throughout the 7 month duration of the study.
For further information about this study please contact the Clinical Trials Research Centre on (03) 9929 8076 or email info@ceruleaclinicaltrials.org.au
- Principal Investigator
Learn more
View this study on ClinicalTrials.gov
See the ClinicalTrials.gov database listing for more detailed information about this study.