REVAKINAGENE TARORETCEL-LWEY IMPLANT
Clinical Criteria Summary
Indication & Patient Population
- Treatment of adults with idiopathic macular telangiectasia type 2 (MacTel)
- Specifically indicated for non-neovascular MacTel
Administration & Dosing Requirements
- Single-dose implant containing 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotropic factor (rhCNTF)
- Requires intravitreal surgical placement
Inclusion Criteria
- Positive diagnosis of MacTel with evidence of fluorescein leakage typical of MacTel
- At least one additional feature: hyperpigmentation outside a 500-micron radius from fovea center, retinal opacification, crystalline deposits, right-angle vessels, or inner/outer lamellar cavities
- Inner Segment-Outer Segment Junction Line (IS/OS) Photoreceptor (PR) break in study eye(s) with en face ellipsoid zone (EZ) area between 0.16 mm² and 2.00 mm² measured by SD-OCT
- Best corrected visual acuity (BCVA) of 54-letter score or better (20/80 or better) on ETDRS chart at screening
- Steady fixation in foveal or parafoveal area with sufficiently clear media for good quality photographs
- Age greater than 21 years and less than 80 years at screening
- Ability to provide written informed consent
- Women of childbearing potential must agree to use highly effective contraception (Germany and France only)
Exclusion Criteria
- Medically unable to comply with study procedures or follow-up visits
- Received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months
- Ever received intravitreal anti-VEGF therapy in the study eye OR received intravitreal anti-VEGF in the fellow eye within the past 3 months at randomization
- Evidence of ocular disease other than MacTel that may confound diagnosis, procedures, or outcome (e.g., glaucoma, severe nonproliferative or proliferative diabetic retinopathy, uveitis)
- Chronic requirement (≥4 weeks at a time) for ocular medications and/or diagnosed disease that may be vision-threatening or affect primary outcome (artificial tears permitted)
- Evidence of intraretinal neovascularization or subretinal neovascularization (SRNV), hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid in either eye
- Evidence of central serous chorio-retinopathy in either eye
- Evidence of pathologic myopia in either eye
- Significant corneal or media opacities in either eye
- History of vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty
- Lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or nuclear opacity > standard 3 (AREDS grading)
- Undergone lens removal in the previous 3 months or YAG laser within 4 weeks
- Participated in any other clinical trial of an intervention within the last 6 months
- Currently on chemotherapy
- Pregnant or breastfeeding
- History of malignancy that would compromise 24-month study survival
- History of ocular herpes virus in either eye
- Physical or mental condition increasing risk of participation or interfering with procedures/assessments
- Evidence of intraretinal hyperreflectivity by OCT
Contraindications
- Active or suspected ocular or periocular infections
- Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM)
Warnings & Precautions
- Severe vision loss
- Infectious endophthalmitis
- Retinal tear and detachment
- Vitreous hemorrhage
- Implant extrusion
- Cataract formation
- Suture related complications
- Delayed dark adaption