Is Encelto (Revakinagene Taroretcel-lwey) implantation suitable for a patient with macular telangiectasia in both eyes, currently on medications including losartan, omeprazole, diltiazem, atorvastatin, and Monjaro (tirzepatide), with significant vision impairment?

Encelto Implantation for Macular Telangiectasia Type 2

Encelto (revakinagene taroretcel-lwey) is appropriate for this patient with non-neovascular MacTel Type 2, provided all exclusion criteria are carefully evaluated and the patient can safely discontinue antithrombotic therapy perioperatively.

Critical Exclusion Criteria Assessment

Before proceeding, the following must be definitively ruled out based on the provided OCT images and clinical documentation:

Absolute Contraindications to Verify

• Neovascular disease: The OCT images must show no evidence of intraretinal or subretinal neovascularization, hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid in either eye, as neovascular MacTel is an absolute exclusion 1
• Intraretinal hyperreflectivity on OCT: This specific finding on OCT imaging is an exclusion criterion that must be absent 1
• Recent anti-VEGF therapy: The patient must not have received intravitreal anti-VEGF therapy in either eye within the past 3 months 1

Medication-Related Considerations

• Antithrombotic discontinuation: The patient is not documented to be on aspirin, NSAIDs, or oral anticoagulants in the medication list provided (losartan, omeprazole, diltiazem, atorvastatin, Monjaro), which satisfies the requirement to temporarily discontinue antithrombotic therapy to reduce vitreous hemorrhage risk 1
• Monjaro (tirzepatide): This GLP-1 receptor agonist for diabetes does not represent a contraindication, though glycemic control should be optimized perioperatively

Disease Stage Confirmation

Non-proliferative MacTel Type 2 is the appropriate indication for Encelto:

• Encelto received FDA approval specifically for idiopathic MacTel Type 2 in March 2025, representing the first approved treatment for this disease 1
• The therapy is designed for non-neovascular disease, as neovascular MacTel is explicitly excluded from treatment 1
• Traditional anti-VEGF therapy (bevacizumab, ranibizumab) has shown no benefit in non-proliferative MacTel Type 2, with studies demonstrating no improvement in visual acuity or central macular thickness at final follow-up 2, 3
• In contrast, proliferative (neovascular) MacTel Type 2 responds to anti-VEGF therapy, making it inappropriate for Encelto 2

Mechanism and Rationale

• Encelto contains 200,000-440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF) in an encapsulated cell-based gene therapy platform 1
• The therapy addresses the underlying neurodegenerative process in MacTel Type 2 rather than vascular leakage, which explains why anti-VEGF therapy fails in non-proliferative disease 4, 1

Surgical Planning Considerations

Sequential Bilateral Treatment

• The plan to treat the right eye first, then proceed with the left eye is appropriate and allows assessment of treatment response and complications before treating the fellow eye
• No specific interval between bilateral treatments is mandated, but clinical judgment should guide timing based on first-eye outcomes

Additional Exclusions to Document

The following must be confirmed absent:

• Ocular comorbidities: No glaucoma, severe diabetic retinopathy, or uveitis 1
• Lens status: No cortical opacity >standard 3, posterior subcapsular opacity >standard 2, or nuclear opacity >standard 3 on AREDS grading 1
• Recent ocular surgery: No lens removal within 3 months or YAG laser within 4 weeks 1
• Infectious risk: No ocular herpes virus history, no active ocular or periocular infection 1
• Other retinal pathology: No central serous chorioretinopathy, pathologic myopia, or significant corneal/media opacities 1

Functional Justification

• The patient's vision impairment threatens employment as a bus driver, with documented difficulty reading, driving, and watching television, establishing medical necessity
• MacTel Type 2 characteristically causes progressive visual decline from neurosensory atrophy and macular pigment depletion 4
• Without treatment, continued progression is expected, as no other effective therapy exists for non-proliferative disease 4

Common Pitfalls to Avoid

• Misclassifying disease stage: Carefully distinguish non-proliferative from proliferative MacTel Type 2, as the latter requires anti-VEGF therapy rather than Encelto 2
• Incomplete exclusion screening: The extensive exclusion criteria list must be systematically evaluated; missing even one contraindication could result in treatment failure or complications 1
• Inadequate documentation: Office visit notes with comprehensive examination findings, fluorescein angiography, and detailed OCT analysis are essential to support the authorization request beyond OCT images alone