]>
IRCT2015020921017N1 IRCT 2017-09-06 Vice Chancellor for Research and Technology, Tehran University of Medical Sciences Co-management of exudative AMD with Avastin and Doxycycline - Comparing the impacts of Doxycycline and placebo added to intraocular Bevacizumab on required numbers of injection and therapeutic progress in patients suffering from exudative Age related Macular Degeneration. 2017-08-23 anticipated 300 Complete https://irct.ir/trial/18528 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this double blinded study, participants will be divided by Block Randomization (Block Size: 6,9,12) into intervention group (n = 200) and placebo control (n = 100). 1-2 wet Age related Macular Degeneration. Intervention 1: Control group: placebo capsules, will be given twice a day for 4 months in addition to standard treatment according to Treat and Extend Regimen. In this regimen, All subjects will receive 1.25 mg intravitreal injections of Bevacizumab administered monthly for 3 treatments. After 3 initial treatments, the interval between treatments will be tailored based on exudative disease activity: eyes will be treated at each visit, no more frequently than every 4 weeks and no less frequently than every 12 weeks. At each visit, patients will be classified as having a dry or wet macula and will be treated monthly until a dry Macula will be achieved (resolution of intraretinal and subretinal fluid on SD OCT and on resolution of subretinal and intraretinal hemorrhage related to exudative AMD). When a dry macula is achieved, the interval between visits will be increased by 2 weeks. If recurrent exudative disease activity will be identified, the interval between visits will be reduced by 2 weeks. These processes will continue until a dry macula will be achieved. Intervention 2: Intervention group 1: in this group, patients will take Doxycycline, 100 mg cap, twice a day, in addition to standard treatment according to Treat and Extend Regimen for 4 months. All subjects will receive 1.25 mg intravitreal injections of Bevacizumab administered monthly for 3 treatments. After 3 initial treatments, the interval between treatments will be tailored based on exudative disease activity: eyes will be treated at each visit, no more frequently than every 4 weeks and no less frequently than every 12 weeks. At each visit, patients will be classified as having a dry or wet macula and will be treated monthly until a dry Macula will be achieved (resolution of intraretinal and subretinal fluid on SD OCT and on resolution of subretinal and intraretinal hemorrhage related to exudative AMD). When a dry macula is achieved, the interval between visits will be increased by 2 weeks. If recurrent exudative disease activity will be identified, the interval between visits will be reduced by 2 weeks. These processes will continue until a dry macula will be achieved. Intervention 3: Intervention group 2: in this group, patients will take Doxycycline, 100 mg cap, twice a day until the completion of induction phase of Treat and Extend Regimen protocol in addition to standard treatment according to Treat and Extend Regimen. All subjects will receive 1.25 mg intravitreal injections of Bevacizumab administered monthly for 3 treatments. After 3 initial treatments, the interval between treatments will be tailored based on exudative disease activity: eyes will be treated at each visit, no more frequently than every 4 weeks and no less frequently than every 12 weeks. At each visit, patients will be classified as having a dry or wet macula and will be treated monthly until a dry Macula will be achieved (resolution of intraretinal and subretinal fluid on SD OCT and on resolution of subretinal and intraretinal hemorrhage related to exudative AMD). When a dry macula is achieved, the interval between visits will be increased by 2 weeks. If recurrent exudative disease activity will be identified, the interval between visits will be reduced by 2 weeks. These process will continue until a dry macula will be achieved.
public Pourya Azimi
No 56, Vesal st., Keshavarz bul., Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 8898 9161 pouryaazimi@gmail.com Student's Scientific Research Center of Tehran University of Medical Sciences scientific Dr. Ahmad Mirshahi
Farabi Comprehensive Center of Excellence in Ophthalmology, Qazvin Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1336616351 +98 21 5540 0003 mirshahi@tums.ac.ir; mirshahia@yahoo.com Farabi Comprehensive Center of Excellence in Ophthalmology, Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: occult choroidal neovascularization (classic CNV); subfoveal age related macular degeneration; naïve patients; central retinal thickness plus subfoveal fluid ≤ 500 µm; lesion size ≤ 2 Disk Diameter; no history for neither systemic disease nor myocardial infarction Exclusion criteria: vitreomacular adhesion; fibrovascular scar; geographic atrophy; history of intraocular pressure rise. 50 years no limit Both H35.3 Degeneration of macula and posterior pole Placebo Treatment - Drugs Treatment - Drugs Control group: placebo capsules, will be given twice a day for 4 months in addition to standard treatment according to Treat and Extend Regimen. In this regimen, All subjects will receive 1.25 mg intravitreal injections of Bevacizumab administered monthly for 3 treatments. After 3 initial treatments, the interval between treatments will be tailored based on exudative disease activity: eyes will be treated at each visit, no more frequently than every 4 weeks and no less frequently than every 12 weeks. At each visit, patients will be classified as having a dry or wet macula and will be treated monthly until a dry Macula will be achieved (resolution of intraretinal and subretinal fluid on SD OCT and on resolution of subretinal and intraretinal hemorrhage related to exudative AMD). When a dry macula is achieved, the interval between visits will be increased by 2 weeks. If recurrent exudative disease activity will be identified, the interval between visits will be reduced by 2 weeks. These processes will continue until a dry macula will be achieved. Intervention group 1: in this group, patients will take Doxycycline, 100 mg cap, twice a day, in addition to standard treatment according to Treat and Extend Regimen for 4 months. All subjects will receive 1.25 mg intravitreal injections of Bevacizumab administered monthly for 3 treatments. After 3 initial treatments, the interval between treatments will be tailored based on exudative disease activity: eyes will be treated at each visit, no more frequently than every 4 weeks and no less frequently than every 12 weeks. At each visit, patients will be classified as having a dry or wet macula and will be treated monthly until a dry Macula will be achieved (resolution of intraretinal and subretinal fluid on SD OCT and on resolution of subretinal and intraretinal hemorrhage related to exudative AMD). When a dry macula is achieved, the interval between visits will be increased by 2 weeks. If recurrent exudative disease activity will be identified, the interval between visits will be reduced by 2 weeks. These processes will continue until a dry macula will be achieved. Intervention group 2: in this group, patients will take Doxycycline, 100 mg cap, twice a day until the completion of induction phase of Treat and Extend Regimen protocol in addition to standard treatment according to Treat and Extend Regimen. All subjects will receive 1.25 mg intravitreal injections of Bevacizumab administered monthly for 3 treatments. After 3 initial treatments, the interval between treatments will be tailored based on exudative disease activity: eyes will be treated at each visit, no more frequently than every 4 weeks and no less frequently than every 12 weeks. At each visit, patients will be classified as having a dry or wet macula and will be treated monthly until a dry Macula will be achieved (resolution of intraretinal and subretinal fluid on SD OCT and on resolution of subretinal and intraretinal hemorrhage related to exudative AMD). When a dry macula is achieved, the interval between visits will be increased by 2 weeks. If recurrent exudative disease activity will be identified, the interval between visits will be reduced by 2 weeks. These process will continue until a dry macula will be achieved. Induction time. Timepoint: monthly after initiation of intervention. Method of measurement: Questionnaire. Number of needed injections to complete Induction phase. Timepoint: monthly after initiation of intervention. Method of measurement: Questionnaire. Final Best Corrected Visual Acuity (BCVA). Timepoint: 12 months after initiation of intervention. Method of measurement: Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Size of neovascularization. Timepoint: 12 months after initiation of intervention. Method of measurement: Questionnaire. Foveal thickness. Timepoint: 12 months after initiation of intervention. Method of measurement: Questionnaire, Optical Coherence Tomography (OCT) records. Relapse: new onset of Intraretinal fluid, Subretinal fluid, Hemorrhage or decrease of BCVA more than 5 scores). Timepoint: 12 months after initiation of intervention. Method of measurement: Questionnaire: physical examination, OCT scan, ETDRS Charts. Vice Chancellor for Research and Technology, Tehran University of Medical Sciences Approved 2016-08-10 Ethics committee of Tehran University of Medical Sciences School of Medicine, Tehran University of Medical Sciences, Enghelab st., Tehran, Iran Tehran Iran (Islamic Republic of)