Clinical study to compare absorption, distribution and elimination of Lupin’s ranibizumab compared with Lucentis®.
- Conditions
- Health Condition 1: H32- Chorioretinal disorders in diseases classified elsewhere
- Registration Number
- CTRI/2023/09/057705
- Lead Sponsor
- Ms Lupin Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Ambulatory men or women participants with age = 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] naive) active@ choroidal
neovascularization (CNV) lesions secondary to AMD. (If both eyes are affected and eligible, at
Investigator’s discretion, only one eye should be selected as the study eye).
3. Best corrected visual acuity (BCVA) in the study eye, using Early Treatment Diabetic Retinopathy
Study (ETDRS) testing, between 20/40 and 20/320 (Snellen equivalent), both inclusive before
pupil dilation.
4. Willingness and ability to undertake all scheduled visits and assessments.
5. Women, who are of non-childbearing potential (surgically sterile or menopausal), OR, if of
childbearing potential using effective birth control and non-pregnant & non-lactating for the
duration of the study.
@Active CNV is defined as presence of leakage or intra- or sub-retinal fluid demonstrated by optical
coherence tomography (OCT) and confirmed by fluorescein angiography (FA)
1. Known hypersensitivity to ranibizumab or any of the components of study medication.
2. Known history of allergy to fluorescein dye.
3. Patients with coexisting CNV lesions secondary to AMD in the non-study eye that would
require simultaneous treatment with anti-VEGF therapies during the study period.
4. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye as assessed by FA.
5. History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study
eye.
6. Any other pathology involving the CNV lesion like retrofoveolar atrophy or permanent
structural damage to fovea.
7. 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.
8. 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
intraocular pressure (IOP)-lowering treatment.
9. History of serious complications following surgery in the study eye within 1 year prior to
randomization.
10. Previous treatment with intravenous anti-VEGF agents or intravitreal anti-VEGF agents such
as Bevacizumab, Ranibizumab, Aflibercept, Pegaptanib, Brolucizumab in either of the eyes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Descriptive assessment of peak systemic drug levels (Cmax) after first doseTimepoint: Proportion of patients with anti-drug antibodies at day 28, 56, & 84. <br/ ><br>Incidence of treatment emergent adverse events
- Secondary Outcome Measures
Name Time Method Descriptive assessment of peak systemic drug levels (Cmax) after third dose. <br/ ><br>Descriptive assessment of trough systemic drug levels (Ctrough) before second & third dose.Timepoint: Proportion of patients with anti-drug antibodies at day 28, 56, & 84. <br/ ><br>Incidence of treatment emergent adverse events