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Non-Proliferative Diabetic RetinopathyPhase 2MAGICNCT05681884

Safety and Efficacy of Faricimab in Patients With NPDR

A Phase 2 study testing Faricimab in people with Non-Proliferative Diabetic Retinopathy, run by Greater Houston Retina Research at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this Phase 2 study is comprised of two groups to evaluate the safety, tolerability, and efficacy of faricimab in patients with Non-Proliferative Diabetic Retinopathy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Proliferative Diabetic Retinopathy
What is being tested?
Faricimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
179 participants
Where
16 sitesUnited States
Study dates
16 May 2023to 26 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide signed IRB-approved informed consent form (ICF) prior to any study-specific procedures
  • Willing and able to comply with clinic visits and study-related procedures and likely to return for all study visits, in the investigator's judgement
  • Men or women \> 18 years of age at the time of signing the Informed Consent Form
  • Diagnosis of diabetes mellitus (type 1 or type 2)
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the final dose of study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a post-menopausal state (\>12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of acceptable contraceptive methods include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
  • Contraception methods that do not result in a failure rate of \< 1% per year such as male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide are not acceptable.
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  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. If a subject is usually not sexually active but becomes active, they, with their partner, must comply with the contraceptive requirements of the study.
  • 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

Who cannot join

  • Any known hypersensitivity to any of the components in the faricimab injection
  • Any known hypersensitivity to any contrast media (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used by the site during the study
  • Active cancer within the past 12 months prior to Screen/Baseline except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤6 and a stable prostate-specific antigen for \>12 months
  • Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Screen/Baseline
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
  • o Women of childbearing potential must have a negative urine pregnancy test at the Screen/Baseline visit for both Group 1 and Group 2. Women of childbearing potential must also have a negative urine pregnancy test on any visit where they will receive treatment with IP or rescue medication. Urine pregnancy tests must be completed prior to the administration of IP/rescue medication and prior to FA being performed.
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  • Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins or minerals) within 3 months (or 5 half-lives, whichever is longer) prior to Screen/Baseline, or during the course of this study
  • Any prior or concomitant systemic anti-VEGF treatment within 4 months prior to Screen/Baseline
  • Any use of any prohibited therapies during times of prohibition.
  • Ocular exclusion criteria for study eye:
  • Subjects who meet any of the following exclusion criteria for the study eye will be excluded from study entry:
  • Any history of treatment with anti-VEGF or any periocular or IVT corticosteroids in the study eye within 4 months prior to Screen/Baseline
  • SD-OCT central subfield thickness (CST) measurement \> 325 µm, in the study eye due to DME.
  • Evidence of infectious ocular infection, in the study eye at Screen/Baseline
  • Any pan-retinal photocoagulation (PRP) treatment received in the study eye prior to Screen/Baseline
  • Retinal vein occlusion in the study eye
  • Cystoid macular edema not attributed to diabetes (instead caused by epiretinal membrane, macular telangiectasia, Coats disease, and inherited retinal diseases) in the study eye
  • Current vitreous hemorrhage obscuring imaging in the study and/or dilated indirect examination
  • Any intraocular surgery (e.g., cataract surgery) within 4 weeks prior to Screen/Baseline in the study eye
  • Active intraocular inflammation including scleritis at screening/baseline

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Austin Retina Associates

    Austin, Texas, 78705

  • California Retina Consultants

    Bakersfield, California, 93309

  • Retina Consultants of Texas

    Beaumont, Texas, 77707

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Mississippi Retina Associates

    Jackson, Mississippi, 39202

  • Retina Consultants of Texas

    Katy, Texas, 77494

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • Retinal Consultants Medical Group

    Modesto, California, 95356

  • Florida Retina Institute

    Orlando, Florida, 32806

  • Retina Consultants of Minnesota St. Louis Park

    Saint Louis Park, Minnesota, 55416

  • Retina Consultants of Texas

    San Antonio, Texas, 78240

  • Retina Group of Florida

    Sarasota, Florida, 34233

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Long Island Vitreoretinal Consultants

    Westbury, New York, 11590

Other trials in United States

About this study

Official title: Faricimab for Retinal Non-Perfusion Associated With Non-Proliferative Diabetic Retinopathy: The MAGIC Phase 2, Multi-Center, Open-Label, Randomized Controlled Trial

The purpose of this Phase 2 study is comprised of two groups to evaluate the safety, tolerability, and efficacy of faricimab in patients with Non-Proliferative Diabetic Retinopathy.

Read the detailed description

Group 1: Subjects will be administered intravitreal faricimab every 4 through week 48 and then will be receive faricimab every 16 weeks with an end of study visit at week 96. 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.

Group 2: Subjects are seen and observed every 16 weeks. Starting at Week 48, subjects will be administered intravitreal faricimab every 4 weeks from week 48 to week 92 with an end of study visit at week 96. At any visit before Week 48, if rescue criteria are met, faricimab will be given every 4 weeks and the subject will continue dosing through the end of the trial.

Being tested
Faricimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FaricimabDrug

    Faricimab is a humanized bispecific antibody binding to human Ang-2 and VEGF. For Phase III studies, the Ro 686-7461 drug product is provided in single-dose 2-mL glass vials (6 mg/0.05 mL) with L-histidine/acetate buffered solution (approximately pH 5.5) containing sodium chloride, sucrose, L-methionine, polysorbate 20, and water for injection.

Study groups in NCT05681884
Study groupRoleWhat they receive
Group 1ExperimentalSubjects 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.
Receives: Drug: Faricimab
Group 2ExperimentalSubjects 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.
Receives: Drug: Faricimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Objective

    Analyze the change in the area of retinal non-perfusion (RNP) within the macula over 48 weeks using ultrawide-field fluorescein angiography (UWFA) within eyes that have NPDR.

    Measured: 48 weeks

  2. Primary Objective

    Analyze the change in the area of retinal non-perfusion (RNP) outside the macula over 48 weeks using ultrawide-field fluorescein angiography (UWFA) within eyes that have NPDR.

    Measured: 48 weeks

Secondary outcomes (9)

  1. Change in area of RNP

    Change in area of RNP, as assessed by a central reading center; linear regression of change in area of RNP (dependent variable) between the monthly faricimab and observation groups, adjusted for age, sex, and disease severity as defined by Baseline ETDRS

    Measured: Baseline through week 96

  2. Change in area of RNP within the macula

    Change in area of RNP within the macula, as assessed by ultrawide-field fluorescein; linear regression of change in area of RNP (dependent variable) between the monthly faricimab and observation groups, adjusted for age, sex, and disease severity as defined by Baseline ETDRS

    Measured: Baseline through week 48 and from baseline through week 96

  3. Change in area of RNP outside of the macula

    Change in area of RNP outside of the macula, as assessed by ultrawide-field fluorescein from baseline to week 96; linear regression of change in area of RNP (dependent variable) between the monthly faricimab and observation groups, adjusted for age, sex, and disease severity as defined by Baseline ETDRS

    Measured: Baseline through week 48 and from baseline through week 96

  4. Percentage of subjects with disease

    Percentage of subjects with neovascularization and/or vitreous hemorrhage and/or DME

    Measured: Baseline through week 96

  5. Mean change in ETDRS

    Mean change in ETDRS BCVA

    Measured: Baseline through week 48 and from baseline through week 96

  6. Mean change in CST

    Mean change in CST

    Measured: Baseline through week 48 and from baseline through week 96

  7. Contrast Sensitivity

    Contrast sensitivity as measured using the quantitative Contrast Sensitivity Function (qCSF) testing on the Manifold Contrast Vision

    Measured: Baseline through Week 48 and from baseline through week 96

  8. Natural History of RNP

    Natural history of RNP through detection of apoptosing retinal cells (DoARC) imaging

    Measured: Baseline through Week 48 and from baseline through week 96

  9. 2-step Improvement in DRSS

    Proportion of subjects with at least a 2-step improvement in DRSS

    Measured: 48 weeks and 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2023
  2. Study start16 May 2023
  3. Primary completion26 Feb 2026
  4. Study completion26 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized during the enrollment phase of the study in a 1:1 ratio to one of two treatment arms.
Masking
None (open label)
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05681884
Sponsor's protocol ID
ML43601
Other IDs
164104
Acronym
MAGIC
Status last verified
Mar 2026
First submitted
4 Nov 2022
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou AW, Sahraravand RA, Baumann LM, Teagle GM, Brown J, Pieramici D, Holy SE, Borne MJ, Wong RW, Cunningham MA, Pearce WA, Rahman EZ, Chang M, Bhavsar AR, Brown DM, Alfaro DV, Fan KC, Cehofski LJ, Ip M, Sadda SR, Lesmes LA, Ehlers JP, Chaudhary V, Al-Khersan H, Wykoff CC. MAGIC: Study Design and Rationale for the Phase 2 Clinical Trial of Faricimab for Non-Proliferative Diabetic Retinopathy. Ophthalmologica. 2026;249(3):265-274. doi: 10.1159/000550491. Epub 2026 Jan 26.

    PubMed 41587134

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Faricimab in people with Non-Proliferative Diabetic Retinopathy, run by Greater Houston Retina Research at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Objective (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05681884, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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