Health Condition 1: H00-H59- Diseases of the eye and adnexa
Conditions
Interventions
Intervention1: Ranibizumab: Ranibizumab PFS delivering 0.5 mg ranibizumab for intravitreal
injection, Dose Formulation: Prefilled syringe (PFS), Dose: 0.5 mg is recommended once a month (approximately
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Participants must sign an ICF indicating that he/she understands the purpose of, and procedures required for the study as described in the Informed consent process (Appendix 10.1.3) and in this protocol and is willing to participate in the study. 2) Male or female greater than or equal to 18 years (completed years) of age at the time of signing the informed consent. 3) Participants who are eligible to receive treatment with IVT ranibizumab as per local prescribing information based on independent judgement of retina specialist. 4) Participants who are currently already receiving IVT Lucentis/Accentrix treatment with at least 3 IVT injections completed. 5) Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR • Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least 45 days after the last dose of the study intervention. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relation to the first dose of the study intervention. • A WOCBP must have a negative test and test method should be a highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of the study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.3. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy.
Exclusion criteria
Exclusion criteria: 1) Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/ excipients thereof (refer to the IB) or drug or other allergies that, in the opinion of the investigator, contraindicate participation in the study. 2) Contraindications to the use of ranibizumab per local prescribing information. 3) Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye at baseline, which is of clinical significance according to the investigator’s judgment, such as active infections of the anterior segment; this includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or autoimmune associated uveitis or endophthalmitis. 4) Any uncontrolled ocular hypertension or glaucoma in the study eye (defined as IOP greater than or equal to 26 mmHg, despite treatment with anti-glaucomatous medication). 5) History of a medical, ocular or non-ocular condition, that in the judgment of the investigator, would preclude a safe administration of the investigational product. 6) Visual Acuity Score (VAS) worse than 20 per 200 on Snellen’s chart, the generally accepted level of legal blindness. 7) Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months before screening. 8) Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol. 9) Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation (approved or investigational) in the study eye at any time during the past 3 months. 10) Treatment with any IVT injection in the study eye within the 28 days prior to day 1. 11) Uncontrolled hypertension (defined as a systolic value = 160 mmHg or diastolic value greater than or equal to 100 mmHg at Screening). 12) Documented medical history (i.e., within 6 months of screening) of thromboembolic events, stroke, congestive heart failure, myocardial infarction, uncontrolled atrial fibrillation. 13) History of excessive bleeding, subconjunctival haemorrhages during the earlier IVT or taking medications can alter bleeding or coagulation. 14) Suspected or active ocular or periocular infection in either eye. 15) History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or renders the patient at high risk for treatment complications in the opinion of the investigator. 16) Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals) within 3 months prior to Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the ability of healthcare providers (HCPs) to follow the Instructions for use (IFU) to prepare and administer a 0.5 mg ranibizumab PFS intravitreal injection to participants while maintaining aseptic conditions in participants who are eligible to receive treatment with ranibizumabTimepoint: Percentage of Successful Task Completions Percentage of PFS Usage Errors on Safety Critical Tasks Percentage of PFS Usage Errors on Essential Tasks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate serious adverse events (SAEs) and adverse events (AEs) that observed within the seven-day study reporting period.Timepoint: Occurrence of ocular AEs/SAEs in the study eye during the study-reporting period | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed