Health Condition 1: H00-H59- Diseases of the eye and adnexa
Conditions
Interventions
Intervention1: Aflibercept Intravitreal injection: Dose: 2 mg (0.05 mL of 40 mg per mL solution) in a single dose vial,
Route of Administration: Intravitreal injection, Duration: 12 weeks (3 doses)
C
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in Appendix 10.1.3 and in this protocol and is willing to participate in the study. 2) Male or female (assigned at birth, inclusive of all gender identities) gender. 3) Age of greater than or equal to 18 years (completed years) at the time of signing the informed consent. 4) Participant with Type 1 or Type 2 diabetes mellitus who present with central DME involvement defined as retinal thickening with a measurement of 300 um or more involving the 1 mm central subfield by SD-OCT] in the study eye at screening and confirmed by the Central Reading Centre (CRC). Note: If both eyes are eligible, the eye with the worse visual acuity will be selected as a study eye. However, the investigator may select the eye with better visual acuity, based on medical reasons or local ethical requirements. 5) BCVA of 78 to 23 letters, inclusive (20 per 32 to 20 per 320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters at screening and baseline. 6) Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis. 7) Criteria removed as per the protocol Version 2.0. 8) Good health as determined by past medical history, physical examination, vital signs, and laboratory tests at screening. 9) Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: i) Is not a woman of childbearing potential (WOCBP) Appendix 4 OR ii) Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4, during the intervention period and for at least 3 months after the last dose of the study intervention. The investigator should evaluate the effectiveness and the potential for failure (e.g., noncompliance, recently initiated) of the contraceptive method in relation to the first dose of the study intervention. iii) A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their own use during the recommended period of contraception. iv) A WOCBP must have a negative highly sensitive serum pregnancy test at screening and urine pregnancy test within 24 hours before the first dose of study intervention. v) If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. vi) Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.6. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy. <br/
Exclusion criteria
Exclusion criteria: 1) Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components or excipients thereof (refer to the locally approved prescribing information of Eylea), or drug or fluorescein or other allergy that, in the opinion of the investigator, contraindicates participation in the study. 2) Contraindications to the use of Eylea as per locally approved prescribing information of Eylea. 3) Had major surgical procedure within 4 weeks before screening, or will not have fully recovered from surgical procedure, or has surgical procedure planned during the time the participant is expected to participate in the study. NOTE: Participants with any planned surgical procedure under local anaesthesia only may participate if they agree to seek prior approval from the investigator and such planned procedure is not expected to prevent, limit, or confound the protocol-specified assessments as assessed by the investigator. 4) Central subfield of the study eye affected by fibrosis or geographic atrophy assessed through colour fundus photography by the CRC at screening. 5) Total area of scarring (involving central subfield) greater than or equal to 50 percentage of the total lesion in the study eye assessed through colour fundus photography by the CRC at screening. Total lesion area is defined as contiguous area of abnormal tissue that will include blood, scars, neovascularization, fibrosis and atrophy. 6) Subretinal haemorrhage in the study eye that involves the centre of the fovea and or the size of the haemorrhage (involving central subfield) is either greater than 50 percentage of the total area of the lesion or greater than or equal to 1 disc area in size at screening as confirmed by CRC. 7) High-risk proliferative diabetic retinopathy (PDR) in the study eye, using any one of the following established criteria for high-risk PDR: i) Any vitreous or pre-retinal haemorrhage ii) Neovascularization elsewhere greater than or equal to 1 or 2 disc area within an area equivalent to the mydriatic ETDRS 7 fields or 4 wide fields on CFPs iii) Neovascularization at disc reater than or equal to 1 or 3 disc area on clinical examination. 8) Prior interventions in the study eye: i) Prior treatment with verteporfin (photodynamic therapy), External beam radiation treatment and Transpupillary thermotherapy in the study eye. ii) Prior any intravitreal injection in the study eye. iii) Prior macular laser photocoagulation (focal or grid or micropulse) in the study eye at any time prior to baseline and peripheral laser photocoagulation in the study eye within 3 months prior to baseline. iv) Prior vitrectomy in the study eye. v) Prior Glaucoma filtration surgery in the study eye. vi) Prior Corneal Transplant in the study eye. vii) Sub-macular surgery or any surgical intervention for DME in study eye. viii) Prior ocular surgery (including cataract) within the previous 3 months from baseline in the study eye. 9) Presence of CNV (confirmed by Central Reading Centre) in either of the 2 eyes due to other causes (based on Investigator s discretion) such as AMD, RVO, ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish clinical equivalence of Aflibercept-Test versus Aflibercept- Reference in participants with DMETimepoint: The mean change from baseline in BCVA, as assessed by ETDRS letters, at Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the efficacy of Aflibercept-Test and Aflibercept-Reference in participants with DME.Timepoint: i) The mean change from baseline in Central subfield thickness (CST), as determined by spectral-domain-optical coherence tomography (SD-OCT) up to Week 12. ii) The mean change from baseline in BCVA, as assessed by ETDRS letters up to Week 12. iii) Proportion of participants who gained greater than or equal to 15 letters from Baseline in BCVA, as assessed in change from baseline in ETDRS letters up to Week 12. iv) Proportion of participants avoiding a loss of greater than or equal to 15, greater than or equal to 10, greater than or equal to 5, or greater than 0 letters in BCVA from baseline over time.;To compare immunogenicity of Aflibercept- Test and Aflibercept-Reference in participants with DME.Timepoint: Incidence of Anti-Drug Antibodies (ADAs) and neutralizing antibodies (nAb) to aflibercept and titer.;To evaluate the ocular and non-ocular safety and tolerability of AfliberceptTimepoint: i) Incidence and severity of ocular adverse events throughout the study. ii) Incidence and severity of non-ocular adverse events throughout the study. | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed