To Study Aqueous Humor Composition and Retinal Imaging Features in Response to Anti-VEGF in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema

Phase 1

Conditions: Treatment Naïve Neovascular Age-Related Macular Degeneration (nAMD) and Treatment Naïve diabetic macular edema (DME)
MedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2020-003515-10-PL

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

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) <= 10%
Ocular Inclusion Criteria for Study Eye with DME
• Participants diagnosed with DME within the last 12 months
• DME defined as thickening on spectral domain optical coherence tomography (SD-OCT) involving the center of the macula: CST of = 325 µm with Spectralis® (Heidelberg Engineering, Heidelberg, Germany)
• Study eye is eligible to be treated with aflibercept, and treatment can be scheduled according to the prescribing information for DME as per label in the study eye
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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