A Study of Ranibizumab in Patients

Phase 3

Conditions: Health Condition 1: H353- Degeneration of macula and posterior pole

Registration Number: CTRI/2021/02/031050

Lead Sponsor: Intas Pharmaceuticals Ltd Biopharma Division

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Male or female participants aged 50 years or more at the time of screening.

2.Written informed consent at Screening must be obtained before any assessment is performed.

3.Willingness and ability to undertake all scheduled visits and assessments.

4.Newly diagnosed, treatment naÃ¯ve patients with active subfoveal choroid neovascularization (CNV) lesion secondary to neovascular (wet) age-related macular degeneration (AMD) in the study eye at Screening and confirmed by the Central

Reading Center (CRC).

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) and must involve central subfield:

a.The area of CNV must be more than 50% of the total lesion area in the study eye confirmed

by the CRC, and

b.Total lesion area more than 9 Disc Areas (DA) in size (including blood, scars and neovascularization) as assessed by FA in the study eye.

c.All subtypes of nAMD CNV lesions are permissible (i.e., classic CNV, occult CNV,

or with some classic CNV component)

5.Good health as determined by past medical history, physical examination, vital signs,

and laboratory tests at screening.

6. BCVA of 20/40 to 20/200 (more then 73 and less then 34 ETDRS letter score) in the study eye using ETDRS chart at a distance of 4 meters at Screening and Baseline.

7.Fellow eye should not be expected to need any anti-VEGF treatment during the initial 8 weeks period of study participation.

Exclusion Criteria

1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, except for:

a.Women whose partners have been sterilized by vasectomy or other means.

b. Women using a highly effective method of birth control (i.e. one that results in a

less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods) is not acceptable).

2.Fertile males, defined as all males physiologically capable of conceiving offspring

UNLESS,

a.the participant agrees to comply with two highly effective contraceptive methods comprising a barrier method (condom or occlusive cap plus spermicide) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child for at least three (3) months following the last study drug administration.

3.Pregnant or nursing (lactating) women.

4.Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by

color fundus photography and confirmed by the CRC at Screening.

5.Total area of scarring more than 50% of the total lesion in the study eye at Screening and confirmed by the CRC, in the study eye.

6.Subretinal hemorrhage in the study eye that involves the center of the fovea and/or the

size of the hemorrhage is either more than 50% of the total area of the lesion or more than 1-disc area in size at screening as confirmed by CRC.

7.Any infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis in either eye within 4 weeks prior to Baseline.

8.Any active intraocular inflammation (grade trace or above) in the study eye within 4

weeks prior to Baseline.

9.History of idiopathic or autoimmune associated uveitis in either eye.

10.CNV in either of the two eyes due to causes other than AMD such as DME, RVO,histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia (spherical equivalent of â??6 diopters or more negative).

11.Prior interventions in the study eye

a.Prior Treatment with verteporfin, External

beam radiation treatment and Transpupillary thermotherapy in the study eye

b.Prior any intravitreal injection in the study eye.

c.Prior laser photocoagulation in the study eye

d.Prior vitrectomy in the study eye

e.Prior Glaucoma filtration surgery in the study eye

f.Prior Corneal Transplant in the study eye

g.Submacular surgery or any surgical intervention for AMD in study eye

h.Prior ocular surgery (including cataract) within the previous 3 months from baseline in the study eye.

12. Prior treatment with

a. Any prior anti-VEGF including Ranibizumab, Bevacizumab, Aflibercept and Pegaptanib (intravitreal or systemic) in either eye

b.Any prior intraocular use of corticosteroids in the study eye

c. Use of topical ocular corticosteroids in the study eye for 60 or more consecutive days within the 90 days period prior to Baseline

d.Use of systemic corticosteroids in the past 6 months.Note: Inhaled, nasal or dermal

steroids are permitted

13.Known hypersensitivity to ranibizumab or any of the components of study medication(histidine HCl,trehal

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish therapeutic equivalence of Intas Ranibizumab versus Ranibizumab-Ref with respect to the change in best corrected visual acuity (BCVA) from Baseline to Week 8 using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale in adult patients with wet AMD.Timepoint: Mean change in BCVA in the study eye from baseline to Week 8 using the ETDRS protocol.

Secondary Outcome Measures

Name	Time	Method
To compare the efficacy of Intas Ranibizumab versus Ranibizumab-Ref at week 24 and 52. <br/ ><br>To compare the efficacy of Intas Ranibizumab with Ranibizumab-Ref based on central foveal thickness, area of choroidal <br/ ><br>neovascularization and leakage from choroidal neovascular lesion.Timepoint: Mean change from baseline in BCVA in the study eye up to 52 weeks using the ETDRS <br/ ><br>protocol. <br/ ><br>Proportion of patients who gained more than 5,10 and 15 letters in the study eye using ETDRS protocol up to 52 weeks. <br/ ><br>Proportion of patients who lost more than 5, 10 and 15 letters in the study eye using ETDRS <br/ ><br>protocol up to 52 weeks <br/ ><br>Mean change from baseline in the total area of leakage from CNV measured by fluorescein angiography (FA) at Weeks 8 and 52.