Comparison of efficacy and safety of BP05 product and product of Lucentis in patients with Wet Age related Macular Degeneration

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Curateq Biologics Private Limited, Curateq Biologics Private Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

22 May 2024 → 14 Oct 2025

Decision date (initial)

2024-07-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Sponsor company

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Therapy

To evaluate the efficacy of a biosimilar candidate BP05 versus Lucentis in patients with wAMD

Secondary objectives 4

1. To evaluate the efficacy of BP05 versus Lucentis in patients with wAMD based on CFT, area of CNV, and leakage from CNV lesion
2. To evaluate the safety of BP05 versus Lucentis
3. To evaluate immunogenicity of BP05 versus Lucentis
4. To evaluate the systemic exposure of BP05 versus Lucentis in patients participating in PK evaluation

Conditions and MedDRA coding

wet macula degeneration

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Patient or patient’s legally authorized representative is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
2. Willing and able to undertake all scheduled visits and assessments as judged by the investigator.
3. Age ≥50 years at Screening
4. Patients diagnosed with active* subfoveal CNV lesion secondary to AMD in the study eye. *Active CNV means presence of leakage as evidenced by FA and intra/subretinal fluid as evidenced by OCT, which should be confirmed by the central reading center at Screening
5. The area of CNV must be ≥50% of the total lesion area in the study eye and confirmed by the central reading center prior to randomization
6. Total lesion area ≤12.0 disc areas in size (including blood, scars, and neovascularizati-on) as assessed by FA in the study eye and confirmed by the central reading center prior to randomization
7. Best corrected visual acuity of 20/40 to 20/200 in the study eye using ETDRS chart at Screening
8. Nonchildbearing potential female (eg, permanently sterilized, postmenopausal [defined as 12 months with no menses without an alternative medical cause prior to Screening]), OR Childbearing potential female patients or male patients with their (respectively male or female) partners who agree to use at least 2 forms of appropriate contraception method that can achieve a failure rate of less than 1% per year from Screening until 3 months after the last IVT injection of the study drug.

Exclusion criteria 37

1. Sub- or intraretinal hemorrhage involving the fovea in the study eye of 50% or more of the total lesion area assessed by FA and confirmed by central reading center.
2. Scarring in the study eye exceeding 50% of total lesion size.
3. Subfoveal fibrosis or atrophy in the study eye assessed by FA and confirmed by central reading center.
4. Presence of CNV in either eye due to non-AMD causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia, assessed by FA and confirmed by central reading center.
5. History or presence of RPE tear or retinal detachment involving the macula in the study eye and fellow eye as assessed by FA and confirmed by central reading center.
6. History or presence of macular hole in the study eye at Screening, confirmed by central reading center.
7. History or clinical evidence of diabetic retinopathy (except for mild non-proliferative diabetic retinopathy) or diabetic macular edema in either eye
8. History of vitrectomy surgery in the study eye.
9. History of trabeculectomy or other filtration surgery in the study eye
10. History of submacular surgery or other surgical intervention for AMD in the study eye
11. Any other intraocular surgery (including cataract surgery) or periocular surgery in the study eye within 90 days prior to randomization, except for lid surgery, which may not have taken place within 30 days prior to randomization
12. Any previous IVT anti-VEGF treatment (eg, bevacizumab, aflibercept, ranibizumab) in either eye
13. Any previous systemic anti-VEGF treatment, within 90 days prior to randomization, and such treatment will not be allowed during the study period.
14. Any systemic treatment or therapy (including prescribed herbal medication) to treat wAMD within 30 days prior to randomization, and such treatment or therapy will not be allowed during the study period. However, dietary supplements, vitamins, or minerals will be allowed.
15. Any IVT injection of corticosteroid (eg, triamcinolone acetonide) or IVT corticosteroid implant in the study eye within 180 days prior to randomization, and such treatment will not be allowed during the study period
16. Topical ocular corticosteroids administered for ≥30 consecutive days in the study eye within 90 days prior to Screening
17. Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia. For patients who have undergone previous refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye must not exceed 8 diopters of myopia
18. Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a yttrium aluminium garnet posterior capsulotomy in association with prior posterior chamber intraocular lens implantation
19. Presence of scleromalacia in either eye
20. Current vitreous hemorrhage in the study eye
21. Active or recent (within 28 days prior to randomization) intraocular, extraocular, and periocular inflammation or infection in either eye
22. History of idiopathic or autoimmune-associated uveitis in either eye
23. Corneal transplant in the study eye
24. Presence of advanced glaucoma or optic neuropathy that involve or threaten the central visual field in the study eye
25. Uncontrolled ocular hypertension in the study eye, defined as IOP ≥30 mmHg despite treatment with antiglaucoma medication
26. History of allergy to the fluorescein sodium for injection in angiography
27. Contraindication for any of the excipients in BP05 or Lucentis (active or suspected ocular or periocular infection, or active severe intraocular inflammation)
28. Reasonable suspicion of a disease or condition that might render the patient at high risk of treatment complications or affect interpretation of the study results (as judged by the investigator)
29. Previous participation in clinical studies of ocular investigational products to treat wAMD in either eye or systemic investigational products to treat wAMD, and such participation will not be allowed during the study period
30. Previous participation in any studies of ocular or systemic investigational products (excluding dietary supplements, vitamins, and minerals) to treat ocular or systemic disease other than wAMD within 90 days prior to randomization, and such participation will not be allowed during the study period even if the investigational product is dietary supplements, vitamins, or minerals
31. Any concurrent ocular condition in the study eye, which in the opinion of the investigator, could either increase the risk to the patient safety or which otherwise may interfere with evaluation of efficacy or safety including, but not limited to ocular media opacities such as corneal opacity or cataract that do not allow proper fundus visualization and fundus imaging, and ocular surface abnormalities, which prevent applanation tonometry during the study period after randomization
32. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the study drug in the opinion of the investigator
33. Pregnant or lactating women. A urine pregnancy test must be required for women of childbearing potential at Screening and must agree to pregnancy prevention throughout the duration of the study.
34. Employees of investigational sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized
35. Stroke, transient ischemic attacks, or myocardial infarction within 90 days prior to randomization
36. History of recurrent significant infections and/or current treatment for active systemic infection.
37. Pharmacokinetic subgroup only: contraindication for additional blood sampling (as judged by the investigator).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in BCVA letters at Week 8, compared with baseline, in the study eye using the ETDRS chart

Secondary endpoints 16

1. Change in BCVA letters over the course of the study compared with baseline in the study eye using the ETDRS chart
2. Change in total size of CNV leakage area at Week 24 and Week 52 compared with baseline in the study eye, as measured by FA
3. Change in total size of CNV at Week 24 and Week 52 compared with baseline in the study eye, as measured by FA
4. Change in CFT at Week 4, Week 8, Week 16, Week 24, and Week 52 compared with baseline in the study eye, as measured by spectral domain OCT
5. Percentage of patients with loss of ≤15 letters using ETDRS, evaluated as change at Week 8, Week 24, and Week 52 compared with baseline in the study eye
6. Percentage of patients with gain of >15 letters using ETDRS, evaluated as change at Week 8, Week 24, and Week 52 compared with baseline in the study eye
7. Change in intra/subretinal fluid status at Week 24 and Week 52 compared with baseline in the study eye, as measured by OCT
8. Number of patients without intra/subretinal fluid at Week 24 and Week 52 in the study eye
9. Drug concentrations (Cmax) analyzed after the collection of blood at the following time points: o Before administration of the study drug at Cycle 1 o 22 hours ± 1 hour after the administration of the first and the sixth dose
10. Incidence of ADAs to ranibizumab measured at pre-dose on Day 1, Week 4, Week 12, Week 20, Week 36, and Week 52
11. Incidence of NAbs will be performed in all the ADA-positive patients
12. Adverse events, as defined by TEAEs, SAEs, AESIs, related TEAEs, and related SAEs
13. Injection site reactions
14. Intraocular inflammation
15. Laboratory parameters (hematology, clinical chemistry, urinalysis, etc.)
16. Intraocular pressure and perfusion of the optic nerve

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Curateq Biologics Private Limited

Sponsor organisation

Curateq Biologics Private Limited

Address

Survey No. 77 And 78, Indrakaran Village, Kandi Mandal, Sangareddy Dist Indrakaran Village Kandi Mandal

City

Hyderabad

Postcode

502329

Country

India

Scientific contact point

Organisation

Curateq Biologics Private Limited

Contact name

Arpitkumar Prajapati

Public contact point

Organisation

Curateq Biologics Private Limited

Contact name

Arpitkumar Prajapati

Curateq Biologics Private Limited

Sponsor organisation

Curateq Biologics Private Limited

Address

Plot No 2 Maitrivihar

City

Hyderabad

Postcode

500038

Country

India

Scientific contact point

Organisation

Curateq Biologics Private Limited

Contact name

Arpitkumar Prajapati

Public contact point

Organisation

Curateq Biologics Private Limited

Contact name

Arpitkumar Prajapati

Third parties 4

Locations

2 EU/EEA countries · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications