CTRI/2020/09/027629
Completed
Phase 3
A Phase III, Comparative, Double Blind, Randomized, Multi-centric 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)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: H318- Other specified disorders of choroid
- Sponsor
- Sun Pharmaceutical Industries Limited
- Enrollment
- 161
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Ambulatory patients of either gender with ââ?°Â¥ 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]
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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