To test different doses of BI836880 in patients with wAMD
Research type
Research Study
Full title
Safety, tolerability and pharmacodynamics of single rising intravitreal and multiple rising intravitreal doses of BI 836880 in patients with wAMD (open label, non-randomized, uncontrolled).
IRAS ID
257363
Contact name
Sobha Sivaprasad
Contact email
Eudract number
2017-001221-40
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
Research summary:
The purpose of this study is to test different doses of an investigational drug, BI 836880, in patients with an eye disease called wet age-related macular degeneration (wAMD).The study will be conducted in 2 parts. BI 836880 will be administered intravitreally as a single dose in the single rising dose (SRD) part and as multiple doses in the multiple rising dose (MRD) part. The main objective of the study is to investigate ocular and systemic safety and tolerability, as well as disease improvement, after both single and multiple injections of different doses.
The study is sponsored by Boehringer Ingelheim, a pharmaceutical company.
Lay summary of results:
A study to test different doses of BI 836880 in patients with an eye disease called wet age-related macular degeneration (wAMD) This is a summary of results from 1 clinical study.
We thank all study participants. You helped us to answer important questions about BI 836880 and the treatment of wet age-related macular degeneration (wAMD).What was this study about?
The purpose of this study was to find the highest dose of a medicine called BI 836880 that people with wet age-related macular degeneration (wAMD) could tolerate. wAMD is a serious disease of the eye. In people with wAMD, blood vessels in the eye do not grow normally. These blood vessels leak fluid or blood into a part of the eye called the macula. The macula is the part of the eye that is responsible for central vision. People with wAMD often have blurred vision. Sometimes they also have a blind spot in their field of vision.Who took part in this study?
People could take part in this study if they:
- were 55 years or older and
- had wet age-related macular degeneration.
In Part 1, the single rising dose (SRD), 15 people took part. There were 10 men and 5 women. The youngest participant was 70 years old, and the oldest participant was 88 years old.
In Part 2, the multiple rising dose (MRD), 27 people took part. There were 15 men and 12 women. The youngest participant was 57 years old, and the oldest participant was 88 years old.
In both parts, the average age was 76 years.How was this study done?
The study was divided in 2 parts.
Part 1
The participants received 5 different doses of BI 836880. The first participants received a low dose and participants who started the study later received higher doses. Participants received 1 single dose of BI 836880.
Participants received between 0.06 mg and 2 mg of BI 836880 injected into the eye. The participants and doctors knew which dose each participant was receiving.
We wanted to find the highest dose of BI 836880 that participants could tolerate. To find out, we looked at the number of participants with any eye-related health problem that doctors think was caused by the medicine, which limits any further increase in the dose.
Part 2
Participants received 2 different doses of BI 836880. The first participants received a low dose and participants who started the study later received a higher dose. Participants received an additional dose of BI 836880 every 4 weeks for a total of 3 doses.
Participants received 1 mg or 2 mg of BI 836880 injected into the eye. The participants and doctors knew which dose each participant was receiving.
We wanted to find out the number of participants with unwanted effects. Unwanted effects are health problems that the doctors think were caused by the study medicine.
The participants were in the study for about 26 weeks.
Participants visited the doctors regularly. During these visits, the doctors collected information about the participants’ health.What were the results of this study?
Part 1
In part 1 of this study, none of the participants had any eye-related health problem that doctors think was caused by the medicine, which limits any further increase in the dose.
Part 2
In part 2 of this study, 6 out of 27 participants (22%) had unwanted effects. The most common unwanted effect was inflammation and blockage of the light sensitive blood vessels at the back of the eye (Retinal occlusive vasculitis).
Some unwanted effects in this study were serious if they led to disability, or the doctor thought they were serious for any other reason. In part 2 of this study, 2 participants had serious unwanted effects. The serious unwanted effect was inflammation and blockage of the light sensitive blood vessels at the back of the eye (retinal occlusive vasculitis).Where did the study take place?
The study was done in Germany, United Kingdom and in the USA.REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0224
Date of REC Opinion
26 Apr 2019
REC opinion
Further Information Favourable Opinion