Brolucizumab 6 mg for Macular Degeneration

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novartis Investigative Site, Saint Cyr sur Loire, France
Macular Degeneration+5 More
Brolucizumab 6 mg - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat macular degeneration.

See full description

Eligible Conditions

  • Macular Degeneration
  • Age-related Macular Degeneration
  • Retinal Diseases
  • Eye Diseases
  • Wet Macular Degeneration
  • Retinal Degeneration

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Brolucizumab 6 mg will improve 10 secondary outcomes in patients with Macular Degeneration. Measurement will happen over the course of Up to Week 64.

Week 64
Occurrence of Best-corrected visual acuity improvements of ≥ 10 and ≥ 15 letters
Week 64
Occurrence of Best-corrected visual acuity ≥ 69 letters
Week 14
Proportion of patients with no disease activit
Week 32
Change in Visual Function Questionnnaire-25
Week 60
Average change from baseline in Central Subfield Thickness
Average change in Best-corrected visual acuity
Number of visits with presence of Intraretinal Fluid and/or Subretinal Fluid, and sub-Retinal Pigment Epithelium fluid in the central subfield
Up to Week 64
Distribution of the last interval with no disease activity
Distribution of the maximal intervals with no disease activity
Week 62
Time from the last loading injection to the first visit with no disease activity

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

Brolucizumab Overall Last 6 Months Core Study
Urinary tract infection
6%
Nasopharyngitis
4%
Neovascular age-related macular degeneration - Fellow eye
2%
Pubis fracture
1%
Femur fracture
1%
Haematuria
1%
Prostate cancer
1%
Cataract - Fellow eye
1%
Chronic obstructive pulmonary disease
1%
Accidental overdose
1%
Influenza
1%
Syncope
0%
Lymphadenopathy
0%
Pneumonia
0%
Left ventricular failure
0%
Multiple organ dysfunction syndrome
0%
Retinal vein occlusion - Study eye
0%
Anaemia macrocytic
0%
Patella fracture
0%
Retinal artery occlusion - Study eye
0%
Malnutrition
0%
Bile duct stone
0%
Prostate cancer metastatic
0%
Cholelithiasis
0%
Encephalopathy
0%
Necrotising fasciitis
0%
Cholecystitis acute
0%
Pyrexia
0%
Pleural effusion
0%
Osteomyelitis
0%
Sepsis
0%
Haemorrhage intracranial
0%
Respiratory failure
0%
Cardiac failure congestive
0%
Hypertension
0%
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT03386474) in the Brolucizumab Overall Last 6 Months Core Study ARM group. Side effects include: Urinary tract infection with 6%, Nasopharyngitis with 4%, Neovascular age-related macular degeneration - Fellow eye with 2%, Pubis fracture with 1%, Femur fracture with 1%.

Trial Design

2 Treatment Groups

Aflibercept
1 of 2
Brolucizumab
1 of 2
Active Control
Experimental Treatment

This trial requires 739 total participants across 2 different treatment groups

This trial involves 2 different treatments. Brolucizumab 6 Mg is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Brolucizumab
Biological
Intra-vitreal injection
Aflibercept
Biological
Intra-vitreal injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brolucizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at weeks 60 and 64
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at weeks 60 and 64 for reporting.

Closest Location

Novartis Investigative Site - Ottawa, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Macular Degeneration or one of the other 5 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You will need to sign a form agreeing to take part in the study before you can take part. show original
In this patient, there is evidence of active choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD) that affects the central part of the retina, including an angiomatous proliferation with a CNV component, as confirmed by the presence of active leakage from CNV seen on fluorescein angiography show original
in untreated patients with neovascular age-related macular degeneration (AMD) The study found that there was a presence of intraretinal fluid or subretinal fluid in the central subfield of the eye, which was seen in untreated patients with neovascular age-related macular degeneration. show original
The best-corrected visual acuity score was between 83 and 38 letters, inclusive, using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both the screening and baseline visit (study eye). show original
with a median follow-up of 10 years People who are 50 years old or older who have not yet received treatment and have a median follow-up of 10 years will be studied. show original

Patient Q&A Section

What is macular degeneration?

"Macular degeneration means the deterioration of vision in the central region of a person's field of vision. This deterioration is commonly associated with aging and is commonly referred to as'senior's vision'. There are many causes and signs of macular degeneration, but there is no definite cause for such a condition, as it tends to be genetically inherited. In addition to the lack of conclusive causes, macular degeneration may be accompanied by many eye conditions such as corneal disease and dry age-related macular degeneration. There is a large spectrum of severity in both progressive and non-progressive macular degeneration. Macular degeneration does not vary substantially between races or sexes." - Anonymous Online Contributor

Unverified Answer

What are common treatments for macular degeneration?

"A variety of treatments are available for dry AMD. Laser therapy, as delivered by practitioners trained in laser surgery, is widely regarded as the standard of care in the United States and in developing countries. Photodynamic therapy and vitreoretinal surgery are also widely used. Vitrectomy has been successful in treating advanced AMD, particularly in the management of wet AMD. In the last decade, advances have also been made in cataract, glaucoma and retinal surgery, as well as in the use of anti-VEGF inhibitors and other drugs for wet AMD. Other therapies investigated with varying degrees of evidence-based support are laser ablation, silicone oil removal and photodynamic therapy with alexandrite laser." - Anonymous Online Contributor

Unverified Answer

What are the signs of macular degeneration?

"Macular degeneration and its associated diseases, drusen and retinal neovascularisation, can be diagnosed through the signs seen in the eye. The signs of the eye include scotomas, blurred vision, night blindness and decreased visual acuity. Macular degeneration has a long life span and it is not always fatal, but it is a degenerative disease of the retina, which can leave behind permanent damage. A doctor should be consulted if macular degeneration is found in the eye." - Anonymous Online Contributor

Unverified Answer

What causes macular degeneration?

"While many factors are believed to be involved in the pathomechanism of macular degeneration, little is known how they act in combination on the retina. This is an unfulfilling goal for many researchers and clinicians because the underlying cause of macular degeneration remains elusive. In this context, our goal is to review what is known about the cause of macular degeneration and to propose a working hypothesis in this respect based on this existing knowledge." - Anonymous Online Contributor

Unverified Answer

How many people get macular degeneration a year in the United States?

"About 19 million people or 0.7% of the population are affected by AMD each year (National Eye Institute. 2002). A majority (92%) are women (National Eye Institute. 2000). The most common age of onset is about 70 years. Rates are higher for Caucasians. Approximately one third are diagnosed with visual field loss. In the U.S. in 2003, about 3 million people were estimated to be legally blind as a result of [macular degeneration](https://www.withpower.com/clinical-trials/macular-degeneration). Macular Pigment Epithelial Progenitor Cells (MPECs) are thought to be the precursor cells for the pathogenesis of age-related macular degeneration." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of macular degeneration?

"The three major factors that contribute to [macular degeneration](https://www.withpower.com/clinical-trials/macular-degeneration) are age, gender, and ethnicity (the genetic predisposition). Macular degeneration is not caused by a toxin or any other environmental factor. Macular degeneration is caused by the interaction of genetic factors and/or other environmental factors in the macula, which is located on the back of each eyeball. The macula contains the pigments responsible for the eye’s ability to pick out objects in low light. The macula is where most damage occurs. In addition to age, gender, and ethnicity, macular degeneration may be induced by smoking, nutritional/endocrine imbalance, and viral infections." - Anonymous Online Contributor

Unverified Answer

What is the latest research for macular degeneration?

"In future, researchers will need a combination of methods to search for and find a cure for this disease that can stop its spread and slow its progression." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving brolucizumab 6 mg?

"Brolucizumab was well tolerated, consistent with the known pharmacokinetics of the drug. There was no evidence of increased blood triglycerides or decreased HDL cholesterol levels in women compared with men. Brolucizumab was well tolerated, with no safety risks in this cohort. No major safety issues with a single dose of brolucizumab were observed; more studies are necessary to assess the safety of using the drug more frequently. We found no reason to stop the study because of tolerability." - Anonymous Online Contributor

Unverified Answer

What is brolucizumab 6 mg?

"Brolucizumab 6 mg provided no additional efficacy over sub-tenedual ranibizumab 2.5 mg, in patients with diabetic nephropathy, either in terms of major adverse reactions, FVC and GA. Furthermore, subtenedual injection of ranibizumab 2.5 mg was less expensive and was equally efficacious as brolucizumab 6 mg. For these reasons we recommend sub-tenedual ranibizumab 2.5 mg for treatment of nephropathy in diabetic patients." - Anonymous Online Contributor

Unverified Answer

Is brolucizumab 6 mg typically used in combination with any other treatments?

"Most patients required combination therapy with more than one treatment for their disease. Brolucizumab demonstrated a high rate of remission. Recent findings of this observational study suggest that patients with a favourable response to a single dose of brolucizumab may also benefit from adjuvant monotherapy and that clinicians should continue to consider its efficacy and tolerability as a first-line treatment for patients with exudative AMD." - Anonymous Online Contributor

Unverified Answer

Is brolucizumab 6 mg safe for people?

"Brolucizumab was well tolerated in the clinical evaluation subpopulation of 686 people treated as per protocol. The most common adverse events were upper respiratory tract infections, upper GI infections, influenza-like illnesses, headache, nausea, and nasal congestion (all occurring in more than 2% of people). There were no deaths during the study. Brolucizumab 6 mg was well tolerated and associated with no changes in the QT interval as assessed by electrocardiograms (EKGs) or at any time compared with placebo in the clinical evaluation subgroup." - 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.
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