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Monoclonal Antibodies
Faricimab for Diabetic Retinopathy (MAGIC Trial)
Phase 2
Recruiting
Research Sponsored by Greater Houston Retina Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ocular inclusion criteria for study eye: Subjects must meet the following ocular inclusion criteria for the study eye for entry into the study: ETDRS BCVA > 20/400 in the study eye, Non-proliferative diabetic retinopathy, as confirmed by the site investigator, Substantial non-perfusion (defined as greater than 5 disc areas on Wide-Field Fluorescein Angiograph (WFFA)), as assessed by site investigator
Diagnosis of diabetes mellitus (type 1 or type 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 48 and from baseline through week 96
Awards & highlights
MAGIC Trial Summary
This trial will assess a new drug to treat Non-Proliferative Diabetic Retinopathy. It will evaluate safety, tolerability and efficacy.
Who is the study for?
Adults over 18 with diabetes (type 1 or type 2) and non-proliferative diabetic retinopathy, who can follow the study schedule. Women must use effective contraception or abstain from sex. Exclusions include recent stroke or heart attack, certain eye treatments, active cancer within a year, pregnancy, and known allergies to study-related substances.Check my eligibility
What is being tested?
The trial is testing Faricimab's safety and effectiveness in treating Non-Proliferative Diabetic Retinopathy (NPDR). Participants are divided into two groups; details on how they're split aren't provided here.See study design
What are the potential side effects?
While specific side effects of Faricimab are not listed here, similar medications often cause eye irritation or discomfort, increased intraocular pressure, bleeding inside the eye, and potential allergic reactions.
MAGIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My study eye has vision better than 20/400, non-proliferative diabetic retinopathy, and significant non-perfusion.
Select...
I have been diagnosed with diabetes (type 1 or type 2).
MAGIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 48 and from baseline through week 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 48 and from baseline through week 96
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Objective
Secondary outcome measures
Change in area of RNP
Change in area of RNP outside of the macula
Change in area of RNP within the macula
+3 moreSide effects data
From 2021 Phase 3 trial • 940 Patients • NCT0362258018%
Cataract
12%
Hypertension
11%
Diabetic retinal oedema
10%
Nasopharyngitis
8%
Conjunctival haemorrhage
6%
Urinary tract infection
4%
Vitreous detachment
4%
Intraocular pressure increased
3%
Vitreous floaters
3%
Fall
2%
Pneumonia
2%
Myocardial infarction
2%
Cardiac failure congestive
2%
Osteomyelitis
2%
Sepsis
1%
Chest pain
1%
Coronary artery disease
1%
Cellulitis
1%
Chronic kidney disease
1%
COVID-19
1%
Cerebrovascular accident
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Syncope
1%
Osteoarthritis
1%
Adenocarcinoma of colon
1%
Cellulitis gangrenous
1%
End stage renal disease
1%
Retinal artery occlusion
1%
COVID-19 pneumonia
1%
Gangrene
1%
Anaemia
1%
Acute left ventricular failure
1%
Acute myocardial infarction
1%
Angina pectoris
1%
Diabetic retinopathy
1%
Diabetic foot infection
1%
Ischaemic stroke
1%
Renal failure
1%
Diabetic foot
100%
80%
60%
40%
20%
0%
Study treatment Arm
C: Aflibercept 2 mg Q8W
A: Faricimab 6 mg Q8W
B: Faricimab 6 mg PTI
MAGIC Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment1 Intervention
Subjects are seen and observed every 16 weeks. Starting at Week 48, subjects will be administered intravitreal faricimab 6 mg every 4 weeks from week 48 to week 92, (defined as every 28 days ± 7 days and at least 21 days between injections) with an end of study visit at week 96.
Rescue: At any visit before Week 48, if rescue criteria are met, faricimab 6mg will be given every 4 weeks and the subject will continue dosing through the end of the trial.
Group II: Group 1Experimental Treatment1 Intervention
Subjects will be administered intravitreal faricimab 6 mg every 4 weeks (defined as every 28 days + 7 days and at least 21 days between injections) through week 48. Starting at Week 48, subjects will be treated every 16 weeks (weeks 48, 64 & 80) with an end of study visit at week 96.
Rescue: At any visit after Week 48, if rescue criteria are met, faricimab 6mg will be given every 4 weeks and the subject will continue dosing through the end of the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Faricimab
2023
Completed Phase 3
~6720
Find a Location
Who is running the clinical trial?
Greater Houston Retina ResearchLead Sponsor
8 Previous Clinical Trials
461 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
340 Patients Enrolled for Diabetic Retinopathy
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,749 Total Patients Enrolled
11 Trials studying Diabetic Retinopathy
1,882 Patients Enrolled for Diabetic Retinopathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stroke or heart attack in the last 6 months.I have not been in a drug or device trial within the last 3 months or 5 half-lives.I haven't taken any anti-VEGF treatments in the last 4 months.My study eye has vision better than 20/400, non-proliferative diabetic retinopathy, and significant non-perfusion.Your study eye has received certain treatments or surgeries in the past few months, has specific eye conditions, or is currently affected by certain issues, which means you cannot participate in the study.I agree to use highly effective birth control or remain abstinent during and 3 months after treatment.I am not pregnant, breastfeeding, nor planning to become pregnant soon.You are not using any treatments that are not allowed during the study.I haven't had active cancer in the last year, except for certain treated early-stage cancers.I am over 18 and can sign the consent form.I have been diagnosed with diabetes (type 1 or type 2).You are allergic to certain eye drops, disinfectants, or anesthetics used in the study.You are allergic to any of the ingredients in the faricimab injection.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitments for this investigation still taking place?
"Evidently, the trial is not actively recruiting as indicated on clinicaltrials.gov; although it was first posted on 15th January 2023 and last updated 25th of that same month. However, there are 114 other studies presently searching for participants."
Answered by AI
How precarious is the situation for individuals in Group 1?
"Given the Phase 2 status of Group 1, there is some evidence for its safety but no data on efficacy. As such, it was assigned a score of 2 on our risk-assessment scale."
Answered by AI
How many sites are engaged in the execution of this research endeavor?
"Currently, 18 clinical trial centres are recruiting patients to participate in this study. These sites are spread across Modesto, Sarasota and Orlando as well as a further 15 cities; it may be beneficial for prospective participants to choose the closest location possible so as to minimize travelling demands."
Answered by AI
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