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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.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015020921017N1
Enrollment
300
Registered
2017-09-06
Start date
2017-08-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

wet Age related Macular Degeneration. Degeneration of macula and posterior pole

Interventions

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 rec
Placebo
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 int
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 re
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 treatm

Sponsors

Vice Chancellor for Research and Technology, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPourya Azimi

Student's Scientific Research Center of Tehran University of Medical Sciences

pouryaazimi@gmail.com+98 21 8898 9161

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026