brolucizumab for Age-Related Macular Degeneration

Novartis Investigative Site, Saint Cys Sur Loire, France
Age-Related Macular Degenerationbrolucizumab - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is to study the long-term effects of the drug brolucizumab on patients with neovascular age-related macular degeneration. The study will last for 56 weeks and will follow patients who have already completed the CRTH258A2303 study.

Eligible Conditions
  • Age-Related Macular Degeneration (AMD)

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Part B High dose
1
AIV007 Treatment Dose 3
1
RO7250284

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Baseline, 52 and 56 weeks

56 weeks
Extended durability of brolucizumab in a Treat-to-Control regimen
Baseline and week 56
Durability of brolucizumab in all patients - as measured by change of the duration of last interval with no disease activity
Durability of brolucizumab in all patients - as measured by duration of the last interval with no disease activity
Durability of brolucizumab in all patients - as measured by duration of the maximal intervals with no disease activity
Week 56
Anatomical outcome of brolucizumab in all patients - as assessed by spectral domain ocular coherence tomography
Anatomical outcome of brolucizumab in all patients - as measured by the change in central subfield thickness
Functional outcomes of brolucizumab in a Treat-to-Control regimen
Functional outcomes of brolucizumab per randomized arm in the core study
up to Week 56
Safety of brolucizumab - as measured by the indicence of ocular and non ocular Adverse Events (AEs)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Part B High dose
1
AIV007 Treatment Dose 3
1
RO7250284

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1 Treatment Group

brolucizumab 6 mg
1 of 1

Experimental Treatment

255 Total Participants · 1 Treatment Group

Primary Treatment: brolucizumab · No Placebo Group · Phase 3

brolucizumab 6 mg
Drug
Experimental Group · 1 Intervention: brolucizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brolucizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 52 and 56 weeks

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,772 Previous Clinical Trials
3,829,923 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
65+100.0%
What site did they apply to?
Novartis Investigative Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%
Average response time
  • < 2 Days
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
References

Frequently Asked Questions

Has brolucizumab acquired approval from the Food and Drug Administration?

"Brolucizumab's safety is supported by Phase 4 trial data, thus receiving the highest score of 3." - Anonymous Online Contributor

Unverified Answer

Are there any remaining openings for individuals to participate in this clinical trial?

"This experiment is currently recruiting candidates, with the initial posting dating back to December 16th 2020. The details have been updated as recently as September 15th 2022 on clinicaltrials.gov." - Anonymous Online Contributor

Unverified Answer

Has brolucizumab been previously tested in other controlled experiments?

"Currently, 10 medical studies involving brolucizumab are active, 5 of which have reached Phase 3. Notably, Porto and Cataluna each host a trial for this drug while there are 360 other locations all over the world running trials as well." - Anonymous Online Contributor

Unverified Answer

What is the aggregate enrollment figure for this clinical trial?

"Indeed, data found on clinicaltrials.gov clearly states that this medical experiment is currently open for enrolment. The trial was initially announced on December 16th 2020 and the most recent update can be dated back to September 15th 2022. A total of 255 participants are required from one single testing site." - Anonymous Online Contributor

Unverified Answer

What is the primary aim of this experiment?

"This trial will evaluate brolucizumab's efficacy over a Baseline, 52 and 56 week duration. Primary outcomes of the study include anatomical changes in intraretinal fluid and/or subretinal fluid, as well as alterations to visual acuity. Secondary objectives focus on assessing ocular and non-ocular Adverse Events (AEs) up to Week 56." - Anonymous Online Contributor

Unverified Answer

Does this clinical trial mark a new milestone in its field of research?

"Novartis Pharmaceuticals initially sponsored the first research of brolucizumab in 2019, which involved 263 patients. After successful Phase 3 drug approval following that study, there are now 10 active trials for this medication across 146 cities and 29 countries." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top