Neovascular age-related macular Degeneration. Exudative age-related macular degeneration
Conditions
Interventions
Intervention 1: Aflibercept (CinnaGen Co, Iran) 2 mg (0.05 mL) by intravitreal injection every 4 weeks (Monthly) for the first 3 ?injections, followed by 2 mg every 8 weeks (every two months) Until we
Sponsors
CinnaGen company
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Inclusion criteria
Inclusion criteria: male or female aged 55-80 years at the time of signing the informed consent form.? Patients with Primary active CNV subfoveal lesion secondary to AMD (with definite diagnosis of AMD ?according to physician’s decision based on the results of ocular examination, or OCT)? the ETDRS-best-corrected visual acuity index with the score of 20/40 to 20/320 (or BCVA letter score of ??73 to 25 in the study eye)? Willing, committed, and able to return for clinic visits and complete all study-related procedures Patients with the ability to read, understand and willing to sign the informed consent form for participation ?in the study
Exclusion criteria
Exclusion criteria: Any prior ocular (in the study eye) or systemic anti-VEGF therapy, during the past 3 months, Photodynamic ?Therapy (PDT) or surgery for neovascular AMD.? The need for receiving ocular anti-VEGF simultaneously in both eyes in the loading phase for the treatment of ?neovascular AMD Scar, fibrosis, or extensive subretinal hemorrhage of more than 50% of the total lesion area in the study eye, ?according to the physician's opinion based on clinical presentation or according to fundus photography.? The presence of scar, fibrosis, or atrophy in the central part of the fovea in the study eye? The presence of retinal pigment epithelial tears or rips involving the macular part of the study eye at the time of ?entering the study The history of any vitreous hemorrhage within 4 weeks prior to the first visit of the study in the study eye? Presence of other causes of CNV in the study eye? Clinical or paraclinical diagnosis of PCV by physician’s diagnosis? The history or clinical evidence of diabetic retinopathy, diabetic macular edema, or any other vascular disease ?affecting the retina, other than AMD in either eyes? Prior vitrectomy in the study eye? History of retinal detachment or treatment or surgery for retinal detachment in the study eye? Any history of a macular hole of stage 2 or above in the study eye? Any intraocular or periocular surgery within three months of the screening visit on the study eye except lid surgery, ?which may not have taken place within one month of screening visit? Prior trabeculectomy or any other filtration surgery in the study eye? Uncontrolled glaucoma (defined as intraocular pressure = 25 mmHg despite treatment with anti-glaucoma ?medication) in the study eye? Active intraocular inflammation in either eye? Active ocular or periocular infection in either eye or any ocular or periocular infection within the last two weeks prior ?to screening visit in either eye? Any history of uveitis in either eye? Presence or history of scleromalacia in either eye? Aphakia or pseudophakia with the absence of posterior capsule (unless it occurred as a result of a yttrium ?aluminum garnet [YAG] posterior capsulotomy) in the study eye Previous therapeutic radiation in the region of the study eye? History of corneal transplant or corneal dystrophy in the study eye? Any significant media opacities, including cataract, in the study eye that might interfere with visual acuity, ?assessment of drug safety, or fundus photography? Patients with amblyopia. Patients with blindness in the fellow eye Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could require either ?medical or surgical intervention during the study period Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the ?risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which ?otherwise may interfere with the injection procedure or with evaluation of efficacy or safety? History of other diseases, 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 the interpretation of the results of the study or render the patient at high risk for treatment complications? Participation as a patient in any clinical study within the 12 weeks prior to the screening visit? The use of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving maintaining vision (losing<15?? ?letter on ETDRS chart) at week 52, in ?comparison to visit 0.?. Timepoint: baseline visit, 52 weeks after first intervention. Method of measurement: Tumbling-E ETDRS chart. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean changes in the Best-Corrected Visual Acuity Index measured with ETDRS chart from visit baseline to week 52?. Timepoint: baseline visit and 52 weeks after first intervention. Method of measurement: Tumbling E ETDRS chart.;The percentage of patients who have increase of =15?? ?score in ETDRS at week 52. Timepoint: baseline visit and 52 weeks after first intervention. Method of measurement: Tumbling E ETDRS chart.;The mean change in National Eye Institute Visual Function Questionnaire (NEI VFQ-25) at week 52 compared to ?the visit baseline. Timepoint: Baseline Visit and 52 weeks after first intervention. Method of measurement: NEI VFQ-25.;Mean changes in central retinal thickness based on structural OCT at week 52 compared to the screening visit?. Timepoint: screening visit? and 52 weeks after first intervention. Method of measurement: Optical Coherence Tumography (OCT).;The percentage of patients without intra-retinal fluid and subretinal fluid based on structural OCT at week 52?. Timepoint: 52 weeks after first intervention. Method of measurement: Optical Coherence tumography.;Systemic and Ophthalmic Adverse events (AEs) and adverse drug reactions (ADR)?? ??– at ?screening, visit 1 and all the follow-up visits until week 52?. Timepoint: All of the study visits. Method of measurement: Physical examination.;Comparing immunogenicity of two products and evaluating antibody formation- at ?screening visit, week 24 and week 52.?. Timepoint: screening visit, 24 weeks, and 52 weeks after first intervention. Method of measurement: ELISA Assay.;Evaluation of blood pressure- at screening visit and week 52?. Timepoint: Screening Visit, 52 weeks after first intervention. Method of measurement: blood pressure meter.;Clinical laboratory testing for systemic safety, including liver and kidney functions, ?complete blood count and clinical bio-chemistries- at regular intervals?. Timepoint: screening visit, 24 weeks and 52 weeks after first intervention. Method of measurement: La | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Nasim Anjidani
Orchid Pharmed Co.
Outcome results
None listed