Health Condition 1: H512- Internuclear ophthalmoplegia
Conditions
Interventions
Intervention1: Bevacizumab: Bevacizumab intravitreal injections
Active ingredient -Bevacizumab
Each vial contains -5 mg in 0.2 ml
Concentration
25 mg/ml
Dose to be administered
1.25 mg
Volume of drug
Sponsors
Reliance life sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients of age = 50 years. 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. 3. Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye. 4. Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements. 5. Menopausal females must have experienced their last period at least 12 months prior to study entry to be classified as not of childbearing potential. Men and women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 60 days following the last dose of study medication.
Exclusion criteria
Exclusion criteria: 1. Treatment with verteporfin photodynamic therapy in the study eye within 6 months or in the non-study eye within 1 week prior to randomization. 2. Previous external-beam radiation therapy, trans-pupillary thermotherapy or subfoveal focal laser photocoagulation in the study eye. 3. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month prior to randomization. 4. CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia. 5. History of submacular surgery or other surgical intervention for AMD, previous intravitreal drug delivery or vitrectomy surgery in the study eye. 6. Current vitreous haemorrhage, subretinal hemorrhage that involves the fovea, subfoveal fibrosis or atrophy, active intraocular inflammation or infection in the study eye 7. History of retinal pigment epithelial tear, rhegmatogenous retinal detachment or macular hole (Stage 3 or 4), aphakia or absence of the posterior capsule in the study eye. 8. Any significant retinal disease other than neovascular AMD such as diabetic retinopathy, retinal vascular occlusion etc. 9. Uncontrolled glaucoma (defined as intraocular pressure of 25 mmHg or more despite treatment with antiglaucoma medications) or history of glaucoma filtering surgery in the study eye 10. Intraocular surgery (including cataract surgery) within 2 months in the study eye prior to enrolment 11. Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either require medical or surgical intervention during the study period, or that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy 12. Presence of/history of idiopathic or autoimmune-associated uveitis in either eye. 13. Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye. 14. Patients with controlled or uncontrolled diabetes mellitus. 15. Patients receiving anticoagulant therapy. 16. PT and aPTT > 1.5 times of ULN 17. Patients who are HIV, HBsAg, HCV test positive. 18. Pregnancy or lactation. 19. Prior use of study medication bevacizumab 20. Use of any other anti-VEGF agents within 3 months or 5 half-lives whichever is longer 21. Hypersensitivity to study drug or any of the excipients in study medication, or history of allergy to fluorescein. 22. Participation in any clinical study of an investigational product within previous 3 months. 23. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study. 24. History of other disease, active systemic infection, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of ocular adverse eventsTimepoint: Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of ocular adverse events at day 28Incidence of non-ocular adverse eventsTimepoint: Day 7 & day 28 | — |
Countries
India
Contacts
Public ContactMr Ganesh Bagul
Reliance life sciences
Outcome results
None listed