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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.

Protocol summary

Summary
Objectives: According to anti-inflammatory effects of Tetracycline and pathophysiology of exudative Age related Macular Degeneration (AMD), the aim of this study is to compare the effect of Doxycycline added to intraocular Bevacizumab on required number of injections and clinical course in patients suffering from wet AMD. Design: This study is the first and the second phase of a randomized, double-blind, placebo-controlled, single-center clinical trial. Three hundred patients with subfoveal exudative AMD will be divided into intervention group (n = 200) and placebo control (n = 100) with Block Randomization (block size of 6, 9 and 12). Setting, conduct and Intervention: In addition to standard treatment by intraocular Bevacizumab based on treat and extent regimen, participants in the intervention group will receive a daily dose of 200 mg of Doxycycline in 2 divided doses. In intervention group, half of the patients will receive Doxycycline until the end of the induction phase while the other half will be treated for 4 months. In control group, patients will receive placebo twice a day for 4 months. Patients eligible for the study: patients who have exudative AMD and haven’t received any other treatment, referred to Farabi hospital. Exclusion criteria: patients with history of systemic disease. Also patients with maximum lesion size of more than 2 Disk Diameters will be excluded. Main outcome variables: Participants will be evaluated for number of injections and induction time as well as foveal thickness, visual acuity, size of neovascularization and relapse of disease.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015020921017N1
Registration date: 2017-09-06, 1396/06/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-06, 1396/06/15
Registrant information
Name
Pourya Azimi
Name of organization / entity
Student's Scientific Research Center of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 9161
Email address
pouryaazimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Co-management of exudative AMD with Avastin and Doxycycline
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
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).

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
School of Medicine, Tehran University of Medical Sciences, Enghelab st., Tehran, Iran
City
Tehran
Postal code
1417613151
Approval date
2016-08-10, 1395/05/20
Ethics committee reference number
IR.TUMS.FARABIH.REC.1395.438

Health conditions studied

1

Description of health condition studied
wet Age related Macular Degeneration
ICD-10 code
H35.3
ICD-10 code description
Degeneration of macula and posterior pole

Primary outcomes

1

Description
Induction time
Timepoint
monthly after initiation of intervention
Method of measurement
Questionnaire

2

Description
number of needed injections to complete Induction phase
Timepoint
monthly after initiation of intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
final Best Corrected Visual Acuity (BCVA)
Timepoint
12 months after initiation of intervention
Method of measurement
Early Treatment Diabetic Retinopathy Study (ETDRS) charts

2

Description
size of neovascularization
Timepoint
12 months after initiation of intervention
Method of measurement
Questionnaire

3

Description
foveal thickness
Timepoint
12 months after initiation of intervention
Method of measurement
Questionnaire, Optical Coherence Tomography (OCT) records

4

Description
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

Intervention groups

1

Description
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.
Category
Placebo

2

Description
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.
Category
Treatment - Drugs

3

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Comprehensive Center of Excellence in Ophthalmology
Full name of responsible person
Dr. Ahmad Mirshahi
Street address
Farabi Comprehensive Center of Excellence in Ophthalmology, Qazvin Square, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Tehran University of Medical Sciences, Office of Vice Chancellor for Research and Technology, Qods St., Keshavarz blvd., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
95-01-43-31872
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Student's Scientific Research Center of Tehran University of Medical Sciences
Full name of responsible person
Pourya Azimi
Position
MD
Other areas of specialty/work
Street address
No 56, Vesal st., Keshavarz bul., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8898 9161
Fax
Email
pouryaazimi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Farabi Comprehensive Center of Excellence in Ophthalmology, Tehran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Mirshahi
Position
professor, MD
Other areas of specialty/work
Street address
Farabi Comprehensive Center of Excellence in Ophthalmology, Qazvin Square, Tehran, Iran
City
Tehran
Postal code
1336616351
Phone
+98 21 5540 0003
Fax
Email
mirshahi@tums.ac.ir; mirshahia@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Student's Scientific Research Center of Tehran University of Medical Sciences
Full name of responsible person
Pourya Azimi
Position
MD
Other areas of specialty/work
Street address
No 56, Vesal st., Keshavarz bul., Tehran, Iran
City
Tehran
Postal code
1417755331
Phone
00
Fax
Email
pouryaazimi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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