Iptacopan for Age-Related Macular Degeneration
Recruiting in Palo Alto (17 mi)
+49 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Novartis Pharmaceuticals
Disqualifiers: Cardiac arrhythmias, Stroke, Myocardial infarction, End stage kidney disease, Malignancy, others
Prior Safety Data
Breakthrough Therapy
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial tests if Iptacopan capsules can prevent worsening of early or intermediate AMD in people who already have severe AMD in one eye. The goal is to see if the medication can protect eye cells and slow down vision loss.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the drug Iptacopan different from other treatments for age-related macular degeneration?
Iptacopan is unique because it targets the complement system, a part of the immune system, which is not the focus of traditional treatments like photodynamic therapy or intravitreal triamcinolone acetonide injections. This novel approach may offer a new way to manage age-related macular degeneration by addressing underlying immune processes.
12345Eligibility Criteria
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.Inclusion Criteria
My eye condition is at risk according to a special eye scan.
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.
+3 more
Exclusion Criteria
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.
I have had a kidney transplant or need dialysis for end-stage kidney disease.
My family has a history of long QT syndrome or Torsades de Pointes.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Iptacopan or placebo oral capsules
24 months
Regular visits throughout the treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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.
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
Iptacopan (LNP023) is already approved in United States for the following indications:
🇺🇸 Approved in United States as Fabhalta for:
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Primary Immunoglobulin A Nephropathy (IgAN)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Opthamalic Consultants of BostonBoston, MA
Novartis Investigative SiteIndianapolis, IN
Novartis Investigative SitePortland, OR
Advanced Research LLC ResearchDeerfield Beach, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Novartis PharmaceuticalsLead Sponsor
References
[ITAP - 6-month results of a prospective, randomised phase 3 study for evaluation of the combination therapy of PDT and intravitreal triamcinolone in exudative AMD]. [2013]Combination therapy of photodynamic therapy (PDT) with intravitreal triamcinolone (IVTA) for choroidal neovascularisation (CNV) in age-related macular degeneration is thought to improve the prognosis. It is therefore widely used, although results are mostly based upon non-randomised and retrospective studies. Here we present the 6-month results of our prospective, randomised, multicentre ITAP trial (Intravitreal Triamcinolone and PDT) for the evaluation of the combination therapy as compared to PDT alone.
Follow-up after intravitreal triamcinolone acetonide for exudative age-related macular degeneration. [2013]To report on the follow-up of patients who received an intravitreal triamcinolone acetonide injection (IVTA) as treatment of exudative age-related macular degeneration.
UK national survey of current practice and experience of intravitreal triamcinolone acetonide. [2016]In recent years, intravitreal triamcinolone acetonide (IVTA) injections have become widely used in the treatment of macular oedema. IVTA can cause elevation of intraocular pressure (IOP), which can be sight threatening. We carried out a nationwide study, which aimed to (i) assess the current usage of IVTA, (ii) estimate the incidence of 'severe' IOP rise following IVTA, in routine practice.
Triamcinolone acetonide as adjunctive treatment to verteporfin in neovascular age-related macular degeneration: a prospective randomized trial. [2018]To examine the use of intravitreal triamcinolone acetonide (IVTA) as adjunctive therapy to photodynamic therapy (PDT) in the treatment of occult and minimally classic choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Intravitreal triamcinolone with photodynamic therapy for subfoveal choroidal neovascularisation in age related macular degeneration. [2019]To report the effects of intravitreal triamcinolone acetonide (iTAAC) injections as an adjunctive treatment to photodynamic therapy (PDT) with verteporfin for new subfoveal choroidal neovascularisation (CNV) in age related macular degeneration (AMD).