Health Condition 1: H32- Chorioretinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Ranibizumab Solution for Injection 10 mg/mL: Single injection of Ranibizumab 0.5 mg (0.05 mL) will be administered intravitreally in the study eye at an interval of at least 4 weeks at
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: AGE RELATED MACULAR DEGENERATION: 1. Ambulatory patients of either gender aged greater than and equal to 50 years 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 CNV secondary to AMD in the study eye 3. Best corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, of 20/40 to 20/320 (Snellen equivalent) 4. Women of childbearing potential must have a negative urine pregnancy test at screening and agree to use highly effective methods of contraception to prevent pregnancy throughout the study (such contraception may include hormonal birth control 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.]. MACULAR OEDEMA DUE TO RVO: 1. Ambulatory patients of either gender aged greater than and equal to 18 years at the time of screening and who are capable of understanding and giving written informed consent. 2. Foveal centre involved Macular oedema secondary to Central RVO or Branch RVO 3. BCVA, using ETDRS chart, of 20/40 to 20/320 (Snellen equivalent) in the study eye before pupil dilation at screening and randomization 5. Women of childbearing potential must have a negative urine pregnancy test at screening and agree to use highly effective methods of contraception to prevent pregnancy throughout the study (such contraception may include hormonal birth control 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.]. DIABETIC MACULAR OEDEMA: 1. Ambulatory patients of either gender aged greater than and equal to 18 years at the time of screening and who are capable of understanding and giving written informed consent. 2. Diabetes mellitus (Type 1 or 2). 3. Retinal thickening secondary to diabetes mellitus (Diabetic macular oedema) involving the center of the fovea 4. BCVA, using ETDRS chart, of 20/40 to 20/320 (Snellen equivalent) in the study eye before pupil dilation at screening and randomization. 5. Women of childbearing po
Exclusion criteria
Exclusion criteria: AGE RELATED MACULAR DEGENERATION: A. Prior/Current treatment 1. Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy, intravitreal drug delivery (steroids or device implantation), anti-VEGF drugs, sub foveal laser photocoagulation, vitrectomy surgery, submacular surgery or other surgical intervention 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 screening. 3. Past or current use of systemic anti-VEGF agents. 4. Previous participation in any studies of investigational drugs within 1 month preceding enrolment (excluding vitamins and minerals) or planning to participate in any other study during the course of this study. B. Ocular conditions in study eye 1. Subfoveal fibrosis or atrophy. 2. Sub retinal haemorrhage that involved the center of the fovea, if the size of the haemorrhage was greater than 50 percent of the total lesion area. 3. Any other concurrent intraocular condition (eg cataract, diabetic retinopathy, the refractive error more than minus 8 diopters of myopia etc.) that, in the opinion of the Investigator, either o May require medical or surgical intervention during study period to prevent or treat visual loss that may have resulted from that condition, or o If allowed to progress untreated, could likely have contributed to loss of at least 2 Snellen equivalent lines of BCVA over the study period. 4. (Stage 3 or 4) 5. Corneal transplant 6. Aphakia or absence of the posterior capsule 7. Active intraocular inflammation (grade trace or above) 8. Uncontrolled glaucoma (defined as intraocular pressure [IOP] greater than and equal to 30 mmHg despite treatment with anti-glaucoma medication) at screening C. Concurrent ocular conditions in either eye 1. Infectious conjunctivitis, keratitis, scleritis, endophthalmitis or any other ocular or periocular infection 2. History of idiopathic or autoimmune-associated uveitis 3. 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 1. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, haematologic, 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. 2. Diabetes mellitus patients with HbA1c more than 7 percent. 3. Patients who are HIV, HBsAg, HCV test positive. 4. Cerebral vascular accident (CVA) or Myocardial Infarction (MI) within 3 months before screening. E. Other Criteria 1. Known hypersensitivity to Ranibizumab or any of the components of study medication. 2. Allergy to fluorescein dye. 3. Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality. 4. Female patients who are pregnant, breastfeeding, planning to be pregnant during the study; male patients whose partners are planning for pregnancy during the study. 5. Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study as well as family members of the employees of Spon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with treatment-emergent adverse events (TEAEs)Timepoint: [Time frame: Throughout the study period] | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients losing fewer than 15 letters (approximately 3 lines) in BCVATimepoint: Baseline (pre-dose Day 1) to Week 4, Week 8 & Week 12;Mean change in BCVATimepoint: Baseline (pre-dose Day 1) to Week 4, Week 8 & Week 12;Proportion of patients who gained at least 15 letters (approximately 3 lines) in BCVATimepoint: Baseline (pre-dose Day 1) to Week 4, Week 8 & Week 12;Mean change in central macular thickness assessed by OCTTimepoint: Baseline (pre-dose Day 1) to Week 12;Mean change in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) composite ScoreTimepoint: Baseline (pre-dose Day 1) to Week 4, Week 8 & Week 12 | — |
Countries
India
Contacts
Public ContactVidya Sethumadhavan
Sun Pharma Laboratories Limited
Outcome results
None listed