A Research Study to Evaluate the Effects of Repeated Intravitreal Injections on Bacteria Around the Eye
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ClinicalTrials.gov Identifier: NCT01531842 |
Recruitment Status : Unknown
Verified February 2012 by Michele Formoso, Mid Atlantic Retina.
Recruitment status was: Recruiting
First Posted : February 13, 2012
Last Update Posted : February 13, 2012
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Condition or disease | Intervention/treatment | Phase |
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Central Retinal Vein Occlusion Choroidal Neovascularization Age-related Macular Degeneration Branch Retinal Vein Occlusion | Procedure: Conj flora Antibiotic resistance | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections |
Study Start Date : | August 2011 |
Estimated Primary Completion Date : | February 2013 |
Estimated Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
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Experimental: Topical antibiotic
Patients will be randomized in a 1:1 fashion to receive a drop of topical antibiotic before and after the intravitreal injection in the +ABX arm (in addition to the typical prep with betadine).
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Procedure: Conj flora Antibiotic resistance
Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine). |
No Antibiotic Arm
No topical antibiotics in the -ABX arm (only the typical prep with betadine)
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Procedure: Conj flora Antibiotic resistance
Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine). |
- Determine if conj bacterial flora demonstrates increased antibiotic resistance if topical antibiotic used pre and post injection vs not used. [ Time Frame: Prior to each of your eye injections for the first 4 injections and continue through the completion of your fourth injection, an anticipated maximum of 6 months. ]Evaluating the effects of repeated use of iodine drops with or without antibiotic eye drops on bacteria on the eye surface in patients undergoing injections in the eye to determine if conjunctival bacterial floar are altered or demonstate increasing antibiotic resistance.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Have been diagnosed with neovascular AMD, CRVO or BRVO.
- Have been determined by the investigator to require intravitreal injections of bevacizumab or ranibizumab.
Exclusion Criteria: Subjects meeting any of the following criteria are ineligible for study entry:
- Prior intraocular injection in either eye.
- Chronic use of opthalmic medication.
- Contact lens wear.
- Ocular surgery within the past 6 months.
- Use of ophthalmic medications in either eye or ocular infection within the past 6 months.
- Use of systemic antibiotics within 6 months.
- Known allergy or contraindication to povidone iodine or fluoroquinolones.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531842
United States, Pennsylvania | |
Wills Eye Institute | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Michele Formoso 215-928-3092 | |
Contact: Jason Hsu, MD 215-928-3300 | |
Principal Investigator: Jason Hsu, M.D. |
Principal Investigator: | Jason Hsu, MD | Mid Atlantic Retina |
Responsible Party: | Michele Formoso, Research Manager, Mid Atlantic Retina |
ClinicalTrials.gov Identifier: | NCT01531842 |
Other Study ID Numbers: |
IRB#11-110 |
First Posted: | February 13, 2012 Key Record Dates |
Last Update Posted: | February 13, 2012 |
Last Verified: | February 2012 |
Conjunctival bacterial flora prophylactic topical antibiotic injection intravitreal injection bacterial resistance serial injection |
serial intravitreal injections CNV CRVO AMD BRVO |
Macular Degeneration Retinal Vein Occlusion Choroidal Neovascularization Neovascularization, Pathologic Retinal Degeneration Retinal Diseases Eye Diseases Metaplasia Pathologic Processes |
Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Choroid Diseases Uveal Diseases Anti-Bacterial Agents Anti-Infective Agents |