Clinical study to compare efficacy and safety of Intas Ranibizumab with Lucentis.
- Conditions
- eovascular (Wet) Age-Related Macular Degeneration (AMD)MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2021-001970-41-LV
- Lead Sponsor
- Intas Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 546
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 naïve 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 =50% of the total lesion area in the study eye confirmed by
the CRC, and
b. Total lesion area =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 (= 73 and = 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 546
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant with exceptions described in the protocol
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 =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 >50% of the total area of the lesion or =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 –6 diopters or more negative).
11. Prior interventions in the study eye described in the protocol
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.
13. Known hypersensitivity to ranibizumab or any of the components of study medication (histidine HCl, a-trehalose dihydrate or polysorbate) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation or to topical anesthetics, mydriatic medications.
14. Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve.
15. History or evidence of the following in the study eye at Screening and/or baseline visit.
16. Use of other investigational drugs (excluding vitamins, minerals) within 30 days (or as per local regulation) or 5 half-lives prior to Baseline whichever is longer, and for neovascular AMD (other than vitamin supplements) in the study eye at any time.
17. History of drug or alcohol abuse within the 12 months prior to baseline.
18. Significant illness within two (2) weeks prior to baseline.
19. History of immunodeficiency diseases, including a positive HIV (ELISA or Western blot) test result. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
20. Presence of uncontrolled systolic blood pressure >160 mmHg or uncontrolled diastolic blood pressure >100 mmHg based on the average of 3 readings taken with the patient in a resting state
21. Documented medical history of thromboembolic events, st
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.<br>;Secondary Objective: • To compare the efficacy of Intas Ranibizumab versus Ranibizumab-Ref at week 24 and 52<br>• To compare the efficacy of Intas Ranibizumab with Ranibizumab-Ref based on central foveal thickness, area of choroidal neovascularization and leakage from choroidal neovascular lesion.<br>• To assess the safety and tolerability Intas Ranibizumab relative to Ranibizumab-Ref<br>• To compare the systemic levels of Intas Ranibizumab with Ranibizumab-Ref<br>• To compare immunogenicity of Intas Ranibizumab with Ranibizumab-Ref<br><br><br><br>;Primary end point(s): Mean change in BCVA in the study eye from baseline to Week 8 using the ETDRS protocol.<br>;Timepoint(s) of evaluation of this end point: Day 57
- Secondary Outcome Measures
Name Time Method