A study to compare the Efficacy, Safety and Immunogenicity of Sun�s Ranibizumab with Reference Biologic in Patients with Neovascular Age-related Macular degeneration (wet AMD)
- Conditions
- Health Condition 1: H318- Other specified disorders of choroid
- Registration Number
- CTRI/2020/09/027629
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 161
1)Ambulatory patients of either gender with � 50 years of age at the time of screening and who are capable of understanding and giving written informed consent.
2)Active primary or recurrent subfoveal lesions with classic or occult choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.
(Please note: Only one eye will be considered for study. If both eyes are eligible, the one with the better visual acuity will be selected for treatment unless, based on medical reasons, the investigator deemed the other eye to be more appropriate for treatment. If both eyes have similar visual acuity and similar medical reasons, then right eye will be selected)
3)Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, of 20/40 to 20/320 (Snellen equivalent) in the study eye before pupil dilation.
4)Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birthcontrol e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence)
[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal
Post-menopausal woman will be defined as: Women not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age]
A.Prior/Concomitant treatment
1)Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy (TTT), intravitreal drug delivery (steroids or device implantation), anti-VEGF drugs, sub foveal laser photocoagulation, vitrectomy surgery, submacular surgery or other surgical intervene for AMD or any other therapy for AMD in the study eye
2)Intraocular surgery (including cataract surgery) in the study eye within 2 months prior to randomization.
3)Past or Concurrent use of systemic anti-VEGF agents
4)Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs
5)Previous participation in any studies of investigational drugs within 1 month preceding randomization (excluding vitamins and minerals) or planning to participate any other study during the course of this study.
6)Treatment with verteporfin photodynamic therapy in the non-study eye less than 7 days preceding day 1.
7)Laser Photocoagulation (juxtafoveal and extrafoveal) in study eye within 1 month prior to randomization.
B.Ocular conditions in study eye
8)Subfoveal fibrosis or atrophy
9)Sub retinal hemorrhage that involved the center of the fovea, if the size of the hemorrhage was > 50% of the total lesion area
10)Retinal pigment epithelial tear that involved the macula
11)Any concurrent intraocular condition in the study eye (e.g., cataract, diabetic retinopathy, the refractive error more than -8 diopters of myopia etc.) that, in the opinion of the investigator, either
ïÆ?Ë?Required medical or surgical intervention during study period to prevent or treat visual loss that may have resulted from that condition, or
ïÆ?Ë?If allowed to progress untreated, could likely have contributed to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the study period
12)Patients with current vitreous hemorrhage or history of (1) rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) (2) glaucoma filtering surgery (3) corneal transplant
13)Aphakia or absence of the posterior capsule
14)Active intraocular inflammation (grade trace or above)
15)Uncontrolled glaucoma in the study eye (defined as intraocular pressure [IOP] � 30 mmHg despite treatment with anti-glaucoma medication)
16)Patients with Polypoidal choroidal vasculopathy (PCV) disease at the time of Screening
C.Concurrent ocular conditions in either eyes
17)Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
18)History of idiopathic or autoimmune-associated uveitis
19)CNV in either eye due to other causes, such as ocular histoplasmosis, trauma or pathologic myopia or CNV lesion not likely to respond to Ranibizumab.
D.Concurrent Systemic Conditions
20)Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, any immunodeficiency and/ or immunosuppressive disease or active systemic infection, cerebral disease that renders the patient incapable of participating in the study.
21)Patients with controlled and uncontrolled Diabetes
E.Other Criteria:
22)Known hypersensitivity to Ranibizumab or any of the components of study medication
23)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients losing fewer than 15 letters (approximately 3 lines) from baseline Best Corrected Visual acuity (BCVA) in the study eye at the end of week 16.Timepoint: Proportion of patients losing fewer than 15 letters (approximately 3 lines) from baseline Best Corrected Visual acuity (BCVA) in the study eye at the end of week 16.
- Secondary Outcome Measures
Name Time Method <br/ ><br>1.Mean change in Best Corrected Visual Acuity (BCVA) <br/ ><br>2. Proportion of patients who gained at least 15 letters (approximately 3 lines) from baseline Best Corrected Visual acuity (BCVA) <br/ ><br>3. Mean Change in central macular thickness assessed by OCT from baseline in the study eye. <br/ ><br>4. Number of Participants with Adverse Events throughout the study. <br/ ><br>5. Proportion of patients with anti-drug antibodies (ADA) and Neutralizing Antibody (NAb). <br/ ><br>Timepoint: 1. from baseline to end of week 16 <br/ ><br>2. from baseline to end of week 16 <br/ ><br>3. from baseline to end of week 16 <br/ ><br>4. throughout the study <br/ ><br>5. at baseline (pre dose Day 1), week 8 and week 16