Clinical trial NCT05511038: A Study to Learn How Safe the Study Drug Intravitreal (Given by an Injection Into the Eye) Aflibercept is in Participants in India With Diabetic Macular Edema
Official title: A Phase IV Interventional Post Approval Trial to Assess the Safety of Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema (DME) in Patients in India.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Researchers are looking for a better way to treat people who have diabetic macular edema (DME).

Diabetic macular edema (DME) is a complication of diabetes. Consistently high blood sugar due to poor glucose control over time can damage small blood vessels in the body, including the eye. Damaged blood vessels in the eye may lead to leakage of the fluid into the central part of the retina at the back of the eye (also called macula) where sharp, straight-ahead vision occurs. Fluid accumulation makes the macula swell and results in reduced vision. If not treated, DME can result in complete loss of central detailed vision.

The study treatment intravitreal aflibercept (also called BAY865321) works by blocking VEGFR-1 receptor activity. Intravitreal aflibercept is already approved in over 105 countries for doctors to prescribe to people with DME. In India, aflibercept is approved conditionally for people with DME. The reason for this is that the sponsor was asked to collect more safety data for intravitreal aflibercept in Indian people with DME.

The main purpose of this study is to collect more data to learn how safe intravitreal aflibercept is in Indian people with DME. To see how safe intravitreal aflibercept is, the researchers will collect the information/data on the medical problems the participants may have during the study, and which may or may not be related to the study treatment. These medical problems are also known as "adverse events" (AEs). AEs will be categorized according to relatedness, seriousness, discontinuation of therapy, action taken and outcome.

The study participants will receive aflibercept as an injection directly into the space in the back of the eye once every 4 weeks in the first 5 months, followed by one injection every 8 weeks for the rest of the study duration. Only one eye per participant to be treated with aflibercept will be considered for the study.

Each participant will be in the study for approximately 52 weeks. The treatment duration will be 48 weeks. For each participant 11 visits to the study site are planned. The study team will perform additional safety calls 16 to 36 hours after each visit starting at visit 2. Alternatively, an additional safety visit can be arranged/planned for the day after treatment.

During the study, the study team will:

* take blood and urine samples
* examine the participants' eyes
* do physical examinations
* examine heart health using ECG
* check vital signs
* ask the participants questions about how they are feeling and what adverse events they are having.
* in- administer the study drug

At the end of the study the participants will be switched to commercially available treatment if recommended by the study doctor/if the participant still benefits from the treatment.


Eligibility criteria: Inclusion Criteria:

* Female or male adult participant ≥18 years of age, with type 1 or 2 diabetes mellitus.
* Participant must have diabetic macular edema (DME) secondary to diabetes mellitus, involving the centre of the macula (defined as the area of the centre subfield of optical coherence tomography (OCT)) in the study eye.
* Decrease in vision, determined to be primarily the result of DME in the study eye.
* Retinal thickness of ≥300 µm in the study eye, as assessed by OCT.
* Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study ( ETDRS) letter score of 73 to 24 (i.e., VA of 20/50 to 20/320) or equivalent in the study eye.
* Participant for whom the decision to initiate treatment with Intravitreal (IVT) aflibercept has been made by the treating Investigator/Physician.
* Willing and able to comply with clinic visits and study-related procedures.
* Provide a signed Informed Consent Form (ICF) prior to any study procedures.

Exclusion Criteria:

* Having any contraindications to the use of IVT aflibercept as listed in the local prescribing information (i.e., ocular or periocular infection, active severe intraocular inflammation, and known hypersensitivity to aflibercept or to any of the excipients).
* History of vitreoretinal surgery and/or scleral buckling in the study eye.
* Ocular conditions with a poorer prognosis in the fellow eye than in the study eye.
* Received previous/ prior treatment as mentioned below:

  * Received anti-Vascular Endothelial Growth Factor (VEGF) drugs in the study eye (pegaptanib sodium, bevacizumab, ranibizumab, etc., including aflibercept) within the last 3 months of Day 1.
  * Received IVT dexamethasone or triamcinolone in the study eye within the last 3 months of Day 1.
  * Received intraocular or periocular corticosteroids in the study eye within the last 4 months of Day 1.
  * Had fluocinolone implant in the study eye within the last 3 years of Day 1.
  * Had dexamethasone implant in the study eye within the last 6 months of Day 1.
  * systemic anti-angiogenic agents within 6 months of Day 1.
* Uncontrolled glaucoma in the study eye (patient who has had filtration surgery in the past, or likely to need filtration surgery in the future).
* Only 1 functional eye even if that eye is otherwise eligible for the study.
* Participated in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
* Pregnant or breast-feeding women.

Primary outcomes:
measure: Number of ocular and non-ocular treatment-emergent adverse events (TEAEs)
timeFrame: At week 52
Secondary outcomes:
measure: Change in best corrected visual acuity (BCVA)
timeFrame: From baseline to week 52
measure: Change in central retinal thickness (CRT)
timeFrame: From baseline to week 52
measure: Proportion of eyes that gain ≥ 5, 10 and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
timeFrame: From baseline to week 52
measure: Proportion of eyes with a ≥2 step improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score
timeFrame: From baseline to week 52
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: L.V. Prasad Eye Institute
state: Andhra Pradesh
city: New Delhi
country: India
facility: Dr. R.P. Centre for Ophthalmic Sciences, AIIMS
state: Delhi
city: Ahmedabad
country: India
facility: M & J Western Regional Institute of Ophthalmology
state: Gujarat
city: Ahmedabad
country: India
facility: Raghudeep Eye Hospital
state: Gujarat
city: Bengaluru
country: India
facility: Narayana Nethralaya
state: Karnataka
city: Bengaluru
country: India
facility: Sankara Eye Hospital
state: Karnataka
city: Chennai
country: India
facility: Medical Research Foundation, Sankara Nethralaya
state: Tamil Nadu
city: Coimbatore
country: India
facility: Lotus Eye Hospital and Institute
state: Tamil Nadu
city: Kolkata
country: India
facility: Disha Eye Hospitals
state: West Bengal
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
References: