CTRI/2025/06/089346尚未招募3 期
A Phase-3, Double-Masked, Two-Arm, Multiple Dose, Parallel Group, Randomized, Multicentre, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Aflibercept Intravitreal Injection and Eylea (Aflibercept) Intravitreal Injection in Patients with Diabetic Macular Oedema (DME)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 34
- 主要终点
- To establish clinical equivalence of
研究概览
简要总结
To compare the efficacy, safety and immunogenicity of aflibercept intravitreal injection and Eylea (Aflibercept) intravitreal injection in patients with Diabetic Macular Oedema (DME)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •Male or female (assigned at birth, inclusive of all gender identities) gender.
- •Age of greater than or equal to 18 years (completed years) at the time of signing the informed consent.
- •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.
- •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.
- •Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis.
- •Criteria removed as per the protocol Version 2.
- •Good health as determined by past medical history, physical examination, vital signs, and laboratory tests at screening.
- •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.
- •vi) Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.
- •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.
- •Willing and able to adhere to the lifestyle restrictions specified in this protocol.
排除标准
- •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.
- •Contraindications to the use of Eylea as per locally approved prescribing information of Eylea.
- •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.
- •Central subfield of the study eye affected by fibrosis or geographic atrophy assessed through colour fundus photography by the CRC at screening.
- •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.
- •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.
- •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.
- •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.
- •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.
- •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.
- •Note: Active CNV indicates the presence of leakage as evidenced by Fluorescein Angiography (FA) and intra- or subretinal fluid as evidenced by Optical Coherence Tomography (OCT).
- •Presence of CNV will be evaluated by the Central Reading Centre, whereas the cause for the same will be assessed by the Investigator.
- •Prior treatment with: i) Anti-VEGF including Aflibercept, Faricimab, Brolucizumab, Ranibizumab, Bevacizumab and Pegaptanib (intravitreal or systemic) in either eye.
- •ii) Intraocular use of corticosteroids in the study eye.
- •iii) Use of topical ocular corticosteroids in the study eye for 60 or more consecutive days within the 90 days period prior to Baseline.
- •iv) Use of systemic corticosteroids for 30 or more consecutive days prior to Baseline.
- •Note: Low stable doses of corticosteroids [defined as less than or equal to 10 mg prednisolone or equivalent dose], inhaled, nasal or dermal steroids are permitted.
- •History or evidence of the following in the study eye at screening and/or baseline visit: i) Retinal pigment epithelium (RPE) rip per tear involving the macula at Screening or Baseline in the study eye.
- •ii) Current vitreous haemorrhage or history of vitreous haemorrhage within 4 weeks prior to Baseline in the study eye.
- •iii) Any macular abnormality (including a history of macular hole stage 2 and above) other than DME at Screening.
- •iv) Uncontrolled glaucoma in the study eye [defined as intraocular pressure (IOP) greater than or equal to 30 mmHg or a cup to disc ratio greater than or equal to 0.8, despite treatment with antiglaucoma medication] and any such condition for which the investigator feels may require a glaucoma-filtering surgery while in the study.
- •v) For participants who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye does not exceed 6 diopters of myopia.
- •vii) Aphakia and or absence of the posterior capsule at Screening or Baseline in the study eye.
- •Absence of an intact posterior capsule is allowed if it occurred as a result of Yttrium Aluminium-Garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation.
- •Any infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis in either eye within 4 weeks prior to baseline.
- •Any active intraocular inflammation (grade trace or above), ocular or periocular infections in the study eye within 4 weeks prior to baseline.
- •History of idiopathic or autoimmune associated uveitis in either eye.
- •Criteria modified as per the protocol Version 2.0: 15.1 Uncontrolled diabetes mellitus as defined by HbA1c greater than or equal to 10 percentage OR fasting blood sugar greater than or equal to 180 mg per dL OR post-prandial blood sugar greater than or equal to 270 mg per dL at screening visit.
- •Uncontrolled blood pressure (defined as systolic greater than 180 mmHg and or diastolic greater than 100 mmHg while a participant is at rest).
- •If blood pressure is out of range, up to 2 repeated assessments are permitted no more than 60 minutes apart.
- •Note: Participants may be re-tested or rescreened after initiation or adjustments of antihypertensive medications to establish control.
- •If a participant blood pressure is controlled by antihypertensive medication, the participant should be taking the same medication and dosage continuously for at least 30 days prior to Day
- •Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.
- •Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention.
- •NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.
- •The life span is limited to less than 6 months.
- •Past or intended use of any disallowed therapies as noted in Section 6.9, prior to the first dose of study intervention.
- •[Specific medications listed in Section 6.9 may be allowed.] 23) Received an investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer, or is currently enrolled in an investigational study.
- •Documented medical history of uncontrolled, clinically significant intercurrent medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
结局指标
主要结局
To establish clinical equivalence of
时间窗: The mean change from baseline in BCVA, as | assessed by ETDRS letters, at Week 8.
Aflibercept-Test versus Aflibercept-
时间窗: The mean change from baseline in BCVA, as | assessed by ETDRS letters, at Week 8.
Reference in participants with DME
时间窗: The mean change from baseline in BCVA, as | assessed by ETDRS letters, at Week 8.
次要结局
- To evaluate the ocular and non-ocular safety(and tolerability of Aflibercept)
- To compare the efficacy of Aflibercept-Test(and Aflibercept-Reference in participants)
- To compare immunogenicity of Aflibercept-(Test and Aflibercept-Reference in)
研究者
Dr Naman Shah
Lambda Therapeutic Research Ltd
研究点 (34)
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