Treatment Naïve Neovascular Age-Related Macular Degeneration (nAMD) and Treatment Naïve diabetic macular edema (DME) MedDRA version: 20.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for All Participants • Investigator deems collection of > 90 micro liter AH is feasible and safe and participant consents to AH collection • Participants who are treatment-naïve in the study eye (e.g., have not received previous treatment with any anti-VEGF IVT, or any corticosteroids periocular or IVT, or any fluocinolone acetonide IVT implant [i.e. Iluvien or Retisert], or laser or verteporfin photodynamic therapy and no such treatment planned for the time between screening and Day 1). • Decreased BCVA is attributable primarily to nAMD or DME, respectively; with an Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letter score of 75 to 20 letters • Clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis and for follow-up • Only one eye can be the study eye; if both eyes are eligible, the eye with the lower BCVA at Day 1 becomes the study eye. If both eyes have the same BCVA, the right eye will be defined as the study eye Inclusion Criteria for nAMD Population • Age>= 50 years Ocular Inclusion Criteria for Study Eye with nAMD • Participants diagnosed with nAMD within the last 12 months. • Participants with subfoveal or juxtafoveal CNV lesion of all types • Study eye is eligible to be treated with aflibercept and treatment can be scheduled according to the prescribing information for nAMD as per label Inclusion Criteria for DME Population • Age >= 18 years • Diagnosis of DM (type 1 or type 2), as defined by the World Health Organization and/or American Diabetes Association • Hemoglobin A1c (HbA1c) =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: Exclusion Criteria for All Participants • Any known hypersensitivity to any contrast media, aflibercept, dilating eye drops, or any of the anesthetics and antimicrobial drops used • Pregnant or breastfeeding woman, or woman intending to become pregnant during the study. • Uncontrolled blood pressure (BP) is defined as systolic > 180 mm Hg and/or diastolic > 100 mm Hg • Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within six months prior to Day 1 or anticipated to require hemodialysis or peritoneal dialysis at any time during the study • History of other diseases, other non-diabetic metabolic dysfunction, that might affect interpretation of the results of the study, or does not allow the participant to follow the visit schedule, or renders the participant at high risk for aflibercept treatment complications in the opinion of the Investigator. • Active cancer within the past 12 months prior to Day 1 • Any major illness or major surgical procedure one month prior to Day 1 • Stroke or myocardial infarction within 12 months prior to Day 1 • Participant has received blood transfusion within three months prior to screening • Any febrile illness within one week prior to Day 1 • Participants who are currently enrolled in or have participated in any other clinical study involving an investigational product or device, or in any other type of medical research, within three months or 5 half-lives (whichever is longer) prior to Day 1 and up to completion of the study • Any illness that causes immunosuppression or any treatment that leads to immunosuppression within 5 half-lives prior to the Day 1 • Use of any systemic corticosteroids within one month prior to Day 1. • Substance abuse within 12 months prior to screening, in the Investigator's judgment • Any prior or concomitant systemic anti-VEGF treatment within six 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 used during the six-month period or 5 half-lives (whichever is longer) prior to Day 1 or likely need to be used. • Any intraocular surgery in the study eye within three months prior to Day 1 or any planned surgery during the study • Any current or history of ocular or intraocular condition that may confound assessment of the macula or affect central vision or could either: o Require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition; or o Preclude any visual improvement due to substantial structural damage. • Treatment for dry eye disease (except eye Lubricants) in the study eye within one month prior to Day 1. • Any active ocular or periocular infections • Any presence of active intraocular inflammation or any history of intraocular inflammation, any history of idiopathic, infectious, or noninfectious uveitis • History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or radiotherapy • Any current ocular condition in the study eye for which, in the opinion of the Investigator, VA loss would not improve from resolution of macular edema • Uncontrolled glaucoma in the study eye • History of glaucoma surgery in the study eye • Any treatment of the study eye with anti-inflammatory eye drops within one month prior to Day 1 • Previous treatment with Iluvien or Retisert in fellow eye (non-study eye) • If participants have been treated with any periocular or IVT corticosteroi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To explore aqueous humor (AH) biomarkers and multimodal imaging features at baseline and over time with and without relation to treatment response • To explore association of genetic polymorphisms with AH biomarkers, multimodal imaging features, and treatment response • To explore whether the biomarkers identified in AH related to treatment response show a similar relationship to treatment response when measured in blood • To describe the relationship between biomarkers of interest in AH and blood at all timepoints tested • To explore the relationship between biomarkers and relevant biochemical pathways in AH at all timepoints tested • To evaluate machine-learning models trained on historic study data for prediction of treatment response;Secondary Objective: NA;Primary end point(s): 1. Values of multimodal imaging features at all timepoints tested 2. BCVA score at all timepoints tested 3. Values of AH biomarkers at all timepoints tested 4. Genotypes 5. Values of selected blood biomarkers at all timepoints tested 6. Values of AH biomarkers of interest at all timepoints tested 7. Values of blood biomarkers of interest at all timepoints tested 8. Pathway analysis based on values of AH biomarkers at all timepoints tested 9. Model performance for predicting treatment response based on clinical, imaging and biomarker baseline values;Timepoint(s) of evaluation of this end point: 1-2. From baseline to Week 28 3. At baseline, at Week 8 and at Week 24 (for nAMD), and baseline, at Week 16 and at Week 24 (for DME) 4. At Baseline 5-7. At baseline, at Week 8 and at Week 24 (for nAMD), and baseline, at Week 16 and at Week 24 (for DME) 8-9. From baseline to Week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Colombia, Czechia, Czech Republic, Italy, Korea, Republic of, Poland, Russian Federation, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed