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Proliferative Sickle Cell RetinopathyPhase 3ALPSNCT07922460

Anti-VEGF Versus Prompt Laser or Observation for Proliferative Sickle Cell Retinopathy (ALPS)

A Phase 3 study testing Faricimab Injection for stage 3 or stage 4 Proliferative sickle cell eyes, Vitrectomy and Laser photocoagulation in people with Proliferative Sickle Cell Retinopathy, run by University of Illinois Chicago at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of the study is to determine if anti-VEGF/anti-Ang2 therapy results in prevention of vitreous hemorrhage or retinal detachment as compared to localized scatter laser photocoagulation in patients with stage 3 Proliferative sickle retinopathy (PSR) and to determine if anti-VEGF therapy results in significant… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Proliferative Sickle Cell Retinopathy
What is being tested?
Faricimab Injection for stage 3 or stage 4 Proliferative sickle cell eyes, Vitrectomy and Laser photocoagulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Dec 2026to 1 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Signed Informed Consent Form
  • Ability to comply with the study protocol
  • Ability and willingness to undertake all scheduled visits and assessments
  • Age 18 years at the time of providing informed consent
  • Sickle cell hemoglobinopathy with active seafans with or without prior laser treatment
  • Visual acuity > 20/40 / > 70 letters on ETDRS chart) for stage 3
Show all 12Show fewer
  • Visual acuity of 20/40 or worse (< 58 letters) for stage 4 PSR and no known prior retinal disease that could explain the visual acuity impairment aside from PSR with vitreous hemorrhage.
  • Ocular inclusion criteria for study eye:
  • Patients who are IVT treatment-naïve in the study eye (i.e., have not received previous treatment with any anti-VEGF IVT or any corticosteroids periocular or IVT in the study eye)
  • Sickle cell hemoglobinopathy with active seafans or vitreous hemorrhage as determined by indirect ophthalmic examination at screening.
  • ETDRS visual acuity of > 70 letters ( > 20/40) at the baseline visit (Day 1) for stage 3 and < 70 letters (20/70 or worse) for stage 4.(see Appendix 7)
  • Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis

Who cannot join

  • Any patient who has undergone major surgery within the past 3 months
  • Diabetes mellitus with evidence of diabetic retinopathy
  • 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 patient during the study
  • History of other diseases, other non-diabetic metabolic dysfunction, physical examination finding, or historical or current clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of the faricimab or that might affect interpretation of the results of the study or renders the patient at high-risk for treatment complications, in the opinion of the investigator
  • Active cancer within the past 12 months prior to Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer
Show all 40Show fewer
  • Stroke (cerebral vascular accident) or myocardial infarction within 12 months prior to Day 1
  • Any febrile illness within 1 week prior to Day 1
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
  • Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of faricimab and a negative urine pregnancy test at the baseline visit (Day 1).
  • Uncontrolled blood pressure, defined as systolic more than 180 mmHg and/or diastolic more than 100 mmHg (while patient is at rest in a sitting position); if a patient's initial reading exceeds these values, a second reading may be taken more or equal than 30 minutes later on the same day
  • Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within 6 months prior to Day 1 or anticipated to require hemodialysis or peritoneal dialysis at any time during the study
  • 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 Day 1, or during the course of this study
  • Substance abuse occurring within 12 months prior to screening, in the investigator's judgment
  • Use of systemic immunomodulatory treatments (e.g., IL 6 inhibitors) within 6 months or 5 half-lives (whichever is longer) prior to Day 1
  • Use of any systemic corticosteroids within 1 month prior to Day 1
  • Systemic treatment for suspected or active systemic infection Note: Ongoing use of prophylactic antibiotic therapy is acceptable
  • Any prior or concomitant systemic anti-VEGF treatment within 6 months or 5 half-lives (whichever is longer) prior to Day 1
  • Use of systemic medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, or ethambutol) during the 6 months (or 5 half-lives, whichever is longer) prior to Day 1
  • Receiving any treatment that leads to immunosuppression within 6 months (or 5 half-lives, whichever is longer) prior to Day 1
  • Requiring continuous use of any medications or treatments listed as prohibited therapy
  • Ocular exclusion criteria for study eye:
  • Traction or rhegmatogenous retinal detachment
  • Other retinovascular conditions such as diabetic retinopathy, retinal vascular occlusion (RAO, RVO)
  • Uncontrolled glaucoma
  • Media opacities precluding fundus photography
  • Any history of or ongoing rubeosis iridis
  • Any history of treatment with anti-VEGF or any periocular or IVT corticosteroids in the study eye prior to Day 1
  • Any treatment for dry eye disease in the last month prior to Day 1 (e.g., cyclosporine eye drops, lifitegrast eye drops). Lubricating eye drops and ointments are permitted.
  • Any intraocular surgery (e.g., cataract surgery) within 3 months prior to Day 1 or any planned surgery during the study
  • Any glaucoma surgery prior to the screening visit
  • History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or radiotherapy
  • Uncontrolled glaucoma (e.g., progressive loss of visual fields or defined as intraocular pressure (IOP) ³25 mmHg at the screening visit despite treatment with anti-glaucoma medication)
  • Any active or suspected ocular or periocular infections on Day 1 (i.e., any active infectious or noninfectious conjunctivitis, keratitis, scleritis, or endophthalmitis)
  • Any presence of active intraocular inflammation on Day 1 (i.e., Standardization of Uveitis Nomenclature [SUN] criteria >0 or National Eye Institute [NEI] vitreous haze grading >0) or any history of intraocular inflammation
  • Ocular exclusion criteria for non-study eye:
  • Non-functioning non-study eye, defined as either:
  • BCVA of hand motion or worse
  • No physical presence of non-study eye (i.e., monocular)
  • Legally blind in the patient's relevant jurisdiction

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • University of Illinois Chicago. Illinois Eye & Ear Infirmary, Department of Ophthalmology and Visual Sciences

    Chicago, Illinois, 60612

    Patrizia A Chavero P, MD, 312-355-0273, pchavero@uic.edu

    Jennifer I Lim, MD

Other trials in United States

About this study

The purpose of the study is to determine if anti-VEGF/anti-Ang2 therapy results in prevention of vitreous hemorrhage or retinal detachment as compared to localized scatter laser photocoagulation in patients with stage 3 Proliferative sickle retinopathy (PSR) and to determine if anti-VEGF therapy results in significant clearing of vitreous hemorrhage and faster improvement of visual acuity as compared to observation

Read the detailed description

This is a phase 3 randomized, controlled, open-label, multicenter clinical trial with 5 to 6 sites in the United States that will enroll up to a total of 50 patients with stage 3 and 4 of Proliferative sickle retinopathy (PSR). There will be a maximum of 30 stage 4 eyes and a minimum of 20 stage 3 eyes

Being tested
Faricimab Injection for stage 3 or stage 4 Proliferative sickle cell eyes, Vitrectomy, Laser photocoagulation
Keywords
PSR, Proliferative sickle cell retinopathy, stage 4 PSR, stage 3 PSR, anti-VEGF therapy, vitreous hemorhage, seafans

What participants receive

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

  • Faricimab Injection for stage 3 or stage 4 Proliferative sickle cell eyesDrug

    Also called Vabysmo, faricimab

    Injection of faricimab 6mg in 0.05 ml intravitreally into the sickle cell eye stage 3 or stage 4

  • VitrectomyProcedure or surgery

    Also called surgery

    pars plana vitrectomy for stage 4 that does not clear by month 4

  • Laser photocoagulationProcedure or surgery

    laser to the retina

Study groups in NCT07922460
Study groupRoleWhat they receive
Stage 3 or 4 Proliferative Sickle Cell Retinopathy Eyes Standard of careActive comparatorlaser for stage 3 and surgery for stage 4
Receives: Procedure: Vitrectomy; Procedure: Laser photocoagulation
Stage 3 or 4 Proliferative Sickle Cell Retinopathy EyesExperimentalInjection of faricimab
Receives: Drug: Faricimab Injection for stage 3 or stage 4 Proliferative sickle cell eyes

What is being measured

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

  1. Seafan Regression

    Resolution of activity of seafan for stage 3

    Measured: 1 year

  2. Vitreous hemorrhage resolution

    resolution of vitreous hemorrhage

    Measured: Month 3

Secondary outcomes (1)

  1. retinal detachment

    detachment of retina from proliferative sickle cell disease

    Measured: 1 year

Timeline

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

  1. First posted6 Nov 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Dec 2029 (estimated)
  4. Study completion1 Dec 2030 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07922460
Sponsor's protocol ID
2026-0362
Other IDs
Roche grant
Acronym
ALPS
Status last verified
Oct 2026
First submitted
2 Nov 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: This is not required and carries an administrative burden for which we do not have personnel

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Faricimab Injection for stage 3 or stage 4 Proliferative sickle cell eyes, Vitrectomy and Laser photocoagulation in people with Proliferative Sickle Cell Retinopathy, run by University of Illinois Chicago at 1 site 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 40 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seafan Regression (time frame: 1 year). 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 NCT07922460.

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 6 Nov 2026.

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