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A Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 with Lucentis® in Patients with Neovascular Age-Related Macular Degeneration

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SLCTR Registration Number

SLCTR/2022/006


Date of Registration

30 Mar 2022

The date of last modification

Mar 31, 2022



Application Summary


Scientific Title of Trial

A Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 with Lucentis® in Patients with Neovascular Age-Related Macular Degeneration


Public Title of Trial

A Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 with Lucentis® in Patients with Neovascular Age-Related Macular Degeneration


Disease or Health Condition(s) Studied

Neovascular Age-Related Macular Degeneration


Scientific Acronym

LRP/LUBT010/2016/008


Public Acronym

None


Brief title

A Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 with Lucentis® in Patients with Neovascular Age-Related Macular Degeneration.


Universal Trial Number

U1111-1275-1785


Any other number(s) assigned to the trial and issuing authority

EudraCT number:2017-004409-42 ClinicalTrials.gov Identifier: NCT04690556


Trial Details


What is the research question being addressed?

Is there equivalence in efficacy, safety, tolerability and immunogenicity of LUBT010 to Lucentis® in terms of visual acuity, in patients with Neovascular Age-Related Macular Degeneration?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Investigators, Healthcare providers


Control

Active


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 3


Intervention(s) planned

The study settings include Durdans Hospital, Colombo 03, National Eye Hospital, Colombo 10, The National Hospital Kandy, Kandy, Jaffna Teaching Hospital, Jaffna and Sri Jayewardenepura General Hospital, Nugegoda.

Method of randomization is block randomization, which is managed by automated Interactive Web Response Systems (IWRS) system.

Eligible patients with Neovascular age related macular degeneration (AMD) will be randomly assigned to receive either LUBT010 (biosimilar of ranibizumab) 0.5 mg (0.05 mL of 10 mg/mL ranibizumab) once monthly (intravitreal injection) or Lucentis® 0.5 mg (0.05 mL of 10 mg/mL ranibizumab) once monthly (intravitreal injection) for 12 months. Patients will be randomized on Day 1. Only one eye per patient will receive the investigational product (IP).

Patients will visit site for a safety visit after the first dose on any one day from Day 2 to Day 9, followed by the next visit on Day 31 ± 2 days, and thereafter monthly for a total of 12 months (i.e. Day 61, Day 91, Day 121, Day 151, Day 181, Day 211, Day 241, Day 271, Day 301, Day 331, and Day 360), with an allowable visit window period of ± 2 days. A post injection visit/ telephonic safety assessment after every injection will be done as deemed necessary by Investigator. Efficacy, safety, and immunogenicity assessments will be done periodically. Day 360 ± 2 will be End of Study (EOS) visit.


Inclusion criteria

  1. Ambulatory male or female participants with age greater than or equal to 50 years at the time of screening who are capable of understanding and giving written informed consent.
  2. Primary or recurrent (anti- Vascular Endothelial Growth Factor (VEGF) naïve) active Choroidal neovascularization (CNV@) lesions involving the foveal center secondary to AMD in any one of the eyes.
  3. Best Corrected Visual Acuity (BCVA) in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) testing, between 20/40 and 20/200 (Snellen equivalent), both inclusive, before pupil dilation.
  4. Willingness and ability to undertake all scheduled visits and assessments.
  5. Females, who are of non-child bearing potential (surgically sterile or menopausal), OR, if of child bearing potential using effective birth control measures and non-pregnant and non-lactating during the study and 3 months after the last dose.

Exclusion criteria

  1. Known hypersensitivity to ranibizumab or any of the components of study medication.
  2. Known history of allergy to fluorescein dye.
  3. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye as assessed by FA (confirmed by independent central reading center).
  4. Subretinal hemorrhage in the study eye that involves the center of the fovea, the size of the hemorrhage is either greater than or equal to 50% of the total lesion area or greater than or equal to 1-disc area in size (confirmed by independent central reading center).
  5. Total lesion area greater than or equal to 12.0-disc areas (DA) in size (including blood, scars, and neovascularization) as assessed by FA in the study eye (confirmed by independent central reading center).
  6. History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye.
  7. Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.
  8. Any other pathology involving the CNV lesion like retro-foveolar atrophy or permanent structural damage to fovea or fibrosis/ hemorrhage involving fovea > 50% of lesion area of study eye that can affect the efficacy of drug.
  9. Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tears or rips involving the macula or macular hole (stage 1 to 4) in the study eye as assessed by FA (confirmed by independent central reading center).
  10. Uncontrolled glaucoma as evident by progressive damage to optic nerve or visual fields despite optimum therapy; or steroid-induced glaucoma with continued use of steroids that requires IOP-lowering treatment.
  11. History of serious complications following surgery in the study eye within 1 year prior to randomization.
  12. Previous treatment with intravenous or intravitreal anti-VEGF agents such as Bevacizumab, Ranibizumab, Aflibercept, Pegaptanib, Brolucizumab in either of the eyes.
  13. Previous external beam radiation or any laser therapy photocoagulation/ thermal laser thermotherapy/verteporfin photodynamic therapy (PDT) involving the foveal center in the study eye within 5 years prior to randomization.
  14. Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser, transpupillary thermotherapy (except subfoveal) in the study eye or use of protein kinase C inhibitors within 3 months prior to randomization.
  15. Previous treatment with intravitreal steroids (e.g., triamcinolone, anecortave acetate) in the study eye within 3 months prior to randomization.
  16. Previous treatment with intravitreal steroid implant (like Ozurdex®) within 6 months prior to randomization.
  17. Concurrent use of systemic anti-VEGF agents.
  18. Intraocular surgery (including cataract surgery) in the study eye within 3 months prior to randomization.
  19. Concurrent treatment with an investigational drug or device in the non-study eye.
  20. Previous participation in any studies of investigational drugs within 30 days or as prescribed in that study (whichever is later) preceding the initial study treatment.
  21. Patients who have DME and/or background or proliferative retinopathy will be excluded. Likewise, any with significant posterior subcapsular cataract (PSC) should be excluded
  22. CNV in the study eye due to causes other than AMD such as histoplasmosis, trauma, or pathological myopia etc. or CNV lesion not likely to respond to ranibizumab.
  23. Active or ongoing ocular infection (e.g. infectious conjunctivitis, keratitis, scleritis, or endophthalmitis) or severe inflammation in either of the eyes.
  24. Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss (of at least 2 Snellen equivalent lines) of BCVA over the 12 months study period (e.g. progressive retinal disease or retinal pathology, cataract, glaucoma, uveitis, previous corneal transplant, the refractive error more than -8 diopters of myopia etc.). The decision regarding exclusion is to be based on the opinion of the Investigator.
  25. Any patient with cloudy media from any cause that prevents adequate visualization of the fundus with indirect ophthalmoscopy should be excluded.
  26. Patients with seropositivity for hepatitis B, hepatitis C, HIV antibody, syphilis tests or any immunodeficiency and/or immunosuppressive disease or active systemic infection.
  27. History or presence of concurrent systemic diseases or dysfunctions requiring significant medical/ surgical intervention during study period that might affect interpretation of the results or contraindicates the use of ranibizumab or render the patient at high risk for treatment complications based on the Investigator’s judgment such as: • Cardiovascular disease (e.g. stroke, myocardial infarction), uncontrolled respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic (e.g. optic neuropathy), metabolic, pulmonary, autoimmune disease or psychiatric disease based on previous history and relevant reports of clinical examination, laboratory tests, or ECG etc.


Primary outcome(s)

1.

Mean change in BCVA from baseline in the study eye at the end of 12, months assessed with the ETDRS chart

[

Time Frame: 12 months

]

Secondary outcome(s)

1.

Mean change in BCVA from baseline in the study eye accessed with the ETDRS chart

[

Time Frame: 3 months, 6 months and 9 months

]
2.

Proportion of patients with anti-drug antibodies

[

Time Frame: 1, 3, 6, 9, and 12 months

]
3.

Adverse Events (AEs) (Number of patients with clinically significant ophthalmic examination findings)

[

Time Frame: Baseline to 12 months

]
4.

Physical & systemic examination (Number of patients with clinically significant physical & systemic examination findings)

[

Time Frame: Baseline to 12 months

]
5.

Vital Signs (Number of patients with clinically significant vital signs findings)

[

Time Frame: Baseline to 12 months

]
6.

ECGs (Number of patients with clinically significant ECG findings)

[

Time Frame: Baseline to 12 months

]
7.

Clinical Laboratory Tests (Number of patients with clinically significant laboratory test findings)

[

Time Frame: Baseline to 12 months

]
8.

Ophthalmic examination (Number of patients with clinically significant ophthalmic examination findings)

[

Time Frame: Baseline to 12 months

]

Target number/sample size

22 (11 in each group)


Countries of recruitment

Bulgaria, Hungary, India, Poland, Slovakia, Ukraine, United States


Anticipated start date

2022-04-05


Anticipated end date

2024-01-05


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Lupin Limited (Biotechnology Division), Jasmine Building, 159, C S T Road, Kalina, Santacruz (E), Mumbai, Maharashtra 400098


Regulatory approvals

Pending



State of Ethics Review Approval


Status

Approved


Date of Approval

2022-01-11


Approval number

P/203/12/2021


Details of Ethics Review Committee

Name: Ethics Review Committee Faculty of Medicine University of Kelaniya
Institutional Address:Ethics Review Committee University of Kelaniya, P.O Box 6, Thalagolla Road, Ragama, Sri Lanka
Telephone:+94 11 2961267
Email: ercmed@kln.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr Charith Fonseka
Consultant Eye surgeon
charith.fonseka@gmail.com
+94 115 410 000
+94777777570

charith.fonseka@gmail.com

Contact Person for Public Queries

Dr Charith Fonseka
Consultant Eye surgeon
charith.fonseka@gmail.com
+94 115 410 000
+94777777570

charith.fonseka@gmail.com


Primary study sponsor/organization

Lupin Limited (Biotechnology Division)

Gat No: 1156, Village Ghotawade, Taluka Mulshi, Pune, Maharashtra, India– 412115



Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description

N/A


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results