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Complement Inhibitor
Iptacopan for Age-Related Macular Degeneration
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study eye (early/intermediate AMD eye) must have at least one high risk optical coherence tomography (OCT) feature (as defined by a central reading center)
Diagnosis of early or intermediate age-related macular degeneration (AMD) in the study eye as determined by the investigator on fundus examination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline/day 1 through month 24
Awards & highlights
Study Summary
This trial will test whether Iptacopan can prevent retinal degeneration in people with early or intermediate AMD.
Who is the study for?
This trial is for men and women over 50 with early or intermediate age-related macular degeneration (AMD) in one eye, who are at high risk as shown by OCT imaging. Participants must be vaccinated against certain infections before treatment starts. Those with recent eye surgery, significant heart issues, kidney failure, cancer history, immune deficiencies or known allergies to study drugs cannot join.Check my eligibility
What is being tested?
The trial is testing Iptacopan's effectiveness in preventing the progression from early or intermediate AMD to more advanced stages of the disease. Participants will either receive Iptacopan or a placebo without knowing which one they're getting to compare outcomes fairly.See study design
What are the potential side effects?
While specific side effects of Iptacopan aren't listed here, common ones may include reactions at the injection site, potential infection risks due to immunosuppression if applicable, and possibly others based on similar medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye condition is at risk according to a special eye scan.
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I have been diagnosed with early or intermediate AMD in one eye.
Select...
My other eye has been diagnosed with wet age-related macular degeneration.
Select...
I have been vaccinated against meningitis and pneumonia before starting LNP023 treatment.
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I am 50 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline/day 1 through month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline/day 1 through month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Development of new incomplete retinal pigment epithelium & outer retinal atrophy or late age-related macular degeneration (AMD) in the early/intermediate AMD eye as determined by optical coherence tomography (OCT) & supported by multimodal imaging
Secondary outcome measures
Change in ETDRS low luminance visual acuity (LLVA) scores in the early/intermediate AMD eye
Change in Early Treatment Diabetic Retinopathy Study (ETDRS) (Standard Luminance) best corrected visual acuity (BCVA) scores in the early/intermediate AMD eye
Change in Standard luminance manifold contrast vision meter contrast sensitivity (MCVM-CS) scores in the early/intermediate AMD eye
+4 moreSide effects data
From 2023 Phase 3 trial • 40 Patients • NCT0482053030%
Headache
18%
Upper respiratory tract infection
18%
COVID-19
15%
Diarrhoea
8%
Constipation
8%
Abdominal pain
8%
Iron deficiency
8%
Pyrexia
8%
Vomiting
3%
Infection
3%
Malignant melanoma
3%
Type 2 diabetes mellitus
3%
Breakthrough haemolysis
3%
Cataract
3%
Pneumonia bacterial
3%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
LNP023 200mg b.i.d.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Iptacopan (LNP023)Experimental Treatment1 Intervention
Iptacopan (LNP023) oral use capsules
Group II: PlaceboPlacebo Group1 Intervention
Placebo matched to study drug, oral use capsules
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iptacopan (LNP023)
2021
Completed Phase 3
~40
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,858 Previous Clinical Trials
4,197,697 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye condition is at risk according to a special eye scan.I have been vaccinated against meningitis and pneumonia before starting LNP023 treatment.I haven't had a stroke or heart attack in the last 6 months and don't have serious heart rhythm problems or severe lung blood pressure issues.My other eye has been diagnosed with wet AMD.I have had a kidney transplant or need dialysis for end-stage kidney disease.I have been diagnosed with early or intermediate AMD in one eye.I have been vaccinated against Haemophilius influenzae if it was available and recommended.My family has a history of long QT syndrome or Torsades de Pointes.I do not have an active Hepatitis B or C infection.I have been vaccinated against Haemophilius influenzae, if it was available and recommended.My other eye has been diagnosed with wet age-related macular degeneration.I have a history of immune system diseases or tested positive for HIV.I currently have active tuberculosis.I have had cancer in any part of my body before.I have been vaccinated against meningitis and pneumonia before starting LNP023 treatment.I have had a solid organ or bone marrow transplant.I am 50 years old or older.I have had meningitis more than once or got meningococcal infection despite being vaccinated.
Research Study Groups:
This trial has the following groups:- Group 1: Iptacopan (LNP023)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT05230537 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative still open to recruitment at the present time?
"According to the latest data from clinicaltrials.gov this medical trial is currently recruiting participants, with initial postings on February 17th 2022 and a most recent update on September 20th."
Answered by AI
How many medical institutions are currently hosting this research endeavor?
"The current trial is enrolling participants from 9 distinct sites, the most prominent being in Austin, Houston and Fort Worth. As such, it would be most convenient to join the study at a clinic located near you to minimize travel requirements."
Answered by AI
How many participants are currently involved in this clinical research?
"Affirmative. According to information published on clinicaltrials.gov, the study is still recruiting participants and was first posted on February 17th 2022 with a most recent update on September 20th 2022. A total of 146 individuals are being sought out from nine locations."
Answered by AI
Could you elaborate on the potential risks of Iptacopan (LNP023) to human health?
"A careful evaluation of the data available has led us to believe that Iptacopan (LNP023) is safe enough to receive a score of 2 on our safety scale. Although there are some reports suggesting it's efficacy, none can be considered conclusive as this drug is currently in Phase 2 clinical trials."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
don't want to be blind.
PatientReceived no prior treatments
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