idiopathic and inflammatory choroidal neovascular membranes
Conditions
Interventions
Product Name: Ranibizumab
Pharmaceutical Form: Solution for injection
Sponsors
University Hospitals Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: inclusion criteria Patients with newly presenting idiopathic and inflammatory choroidal neovascularisation •have a best-corrected log MAR visual acuity in the study eye between 73-24 letters •have a CNV lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography: -Evidence that CNV extends under the geometric centre of the foveal avascular zone -The area of the CNV must occupy at least 50% of the total lesion. -The lesion must be =5400 microns in greatest linear dimension (GLD) -No subfoveal atrophic change, no subfoveal fibrosis. Area of fibrosis less than or equal to 50% of total lesion area. -for occult with no classic CNV, the lesion must have presumed recent disease progression as assessed by the Investigator and defined as having at least one of the following criteria: -Blood associated with the lesion at baseline -=10% increase in the GLD as assessed by fluorescein angiography in the previous 3 months -Loss of VA in the previous 3 months defined as either =5 letters logMAR vision as determined by protocol refraction and protocol measurement or 2 or more lines using a Snellen chart by standard examination - Presence of subretinal fluid on OCT Both male and female patients will be recruited and most of the patient are likely to be young. Most of the patients will be on oral steroids and systemic immunosuppression and that shall be continued at the discretion of treating ophthalmologist. The dose of these may be increased if the PSII was deemed to be uncontrolled but not just for treating the CNVM Prior treatment with transpupillary thermotherapy (TTT), thermal laser, or verteporfin therapy (PDT) in the study eye Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0, •Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (Macugen® , Avastin® , anecortave acetate) •Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye •History of vitrectomy surgery in the study eye •History of greater than mild non-proliferative diabetic retinopathy or any diabetic maculopathy •History of retinal vascular occlusions •History of glaucoma filtering surgery in the study eye •History of corneal transplant in the study eye •Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) •Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either >50% of the total lesion area| or >1 disc areas in size •Subfoveal fibrosis or atrophy in the study eye. Area of fibrosis > 50% of total lesion area •CNV in either eye due to AMD •Retinal pigment epithelial tear involving the macula in the study eye •Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 24-month study period •Current vitreous hemorrhage in the study eye •History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye • Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye • Aphakia or absence of the posterior capsule in the study eye Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation. •Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia or signs of pathologic myopia with a refraction of 4-8 diopters For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed -8 diopters of myopia. • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0 •Uncontrolled glaucoma in the study eye (defined as intraocular pressure >30 mmHg despite treatment with anti-glaucoma medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of intravitreal Lucentis (Ranibizumab) treatment for inflammatory choroidal neovascularis membranes secondary to posterior segment intraocular inflammation (PSII)or presumed to be secondary to inflammation (idiopathic). Various treatments tried so far include oral/intravenous/intraocular steroids,systemic immuosuppression, Photodynamic therapy or a combination of treatment with variable results. Inravitreal injection of Ranibizumab may help in resolution of CNVM secondary to PSII avoiding the need of systemic therapies. The primary outcome measure is to assess the likelihood of a moderate loss of vision. ;Secondary Objective: The secondary objective is to compare the results with ours and other case series of patients who have already been treated with various combination treatments over the last few years. ;Primary end point(s): The proportion of subjects who gain 15 or more letters of best corrected visual acuity at 12 months compared to baseline, based on the ETDRS visual acuity chart. | — |
Countries
United Kingdom
Outcome results
None listed