Central Retinal Vein OcclusionNCT01531842
A Research Study to Evaluate the Effects of Repeated Intravitreal Injections on Bacteria Around the Eye
A study testing Conj flora Antibiotic resistance in people with Central Retinal Vein Occlusion and Choroidal Neovascularization, run by Mid Atlantic Retina at 1 site in United States.
Trial summary
This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Retinal Vein Occlusion, Choroidal Neovascularization, Age-related Macular Degeneration
- What is being tested?
- Conj flora Antibiotic resistance
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wills Eye Institute
Philadelphia, Pennsylvania, 19107
Michele Formoso, 215-928-3092
Jason Hsu, MD, 215-928-3300
About this study
Official title: Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections
This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye.
Read the detailed description
The primary objective of this study is to determine whether conjunctival bacterial flora are altered and/or demonstrate increasing antibiotic resistance after serial intravitreal injections when a prophylactic topical antibiotic is used pre- and post-injection compared to when they are not used.
- Conditions
- Central Retinal Vein Occlusion, Choroidal Neovascularization, Age-related Macular Degeneration, Branch Retinal Vein Occlusion
- Being tested
- Conj flora Antibiotic resistance
- Keywords
- Conjunctival bacterial flora, prophylactic topical antibiotic, injection, intravitreal injection, bacterial resistance, serial injection, serial intravitreal injections, CNV, CRVO, AMD, BRVO
- Medical subject headings
- Retinal Vein Occlusion, Choroidal Neovascularization, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conj flora Antibiotic resistanceProcedure or surgery
Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine).
| Study group | Role | What they receive |
|---|---|---|
| Topical antibiotic | Experimental | 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). Receives: Procedure: Conj flora Antibiotic resistance |
| No Antibiotic Arm | Other | No topical antibiotics in the -ABX arm (only the typical prep with betadine) Receives: Procedure: Conj flora Antibiotic resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if conj bacterial flora demonstrates increased antibiotic resistance if topical antibiotic used pre and post injection vs not used.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionFeb 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Retinal Vein OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mid Atlantic Retina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Formoso, Mid Atlantic Retina
- Investigators
- Jason Hsu, MD, Principal investigator, Mid Atlantic Retina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531842
- Sponsor's protocol ID
- IRB#11-110
- Status last verified
- Feb 2012
- First submitted
- 13 Oct 2011
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections
- ClinicalTrials.gov ID
- NCT01531842
- Acronym / sponsor ID
- IRB#11-110
- Conditions
- Central Retinal Vein Occlusion, Choroidal Neovascularization, Age-related Macular Degeneration, Branch Retinal Vein Occlusion
- Keywords
- Conjunctival bacterial flora, prophylactic topical antibiotic, injection, intravitreal injection, bacterial resistance, serial injection, serial intravitreal injections, CNV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mid Atlantic RetinaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye.
Detailed description
The primary objective of this study is to determine whether conjunctival bacterial flora are altered and/or demonstrate increasing antibiotic resistance after serial intravitreal injections when a prophylactic topical antibiotic is used pre- and post-injection compared to when they are not used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical antibiotic | Experimental | Procedure: Conj flora Antibiotic resistancePatients 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). |
| No Antibiotic Arm | Other | Procedure: Conj flora Antibiotic resistanceNo topical antibiotics in the -ABX arm (only the typical prep with betadine) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conj flora Antibiotic resistancePatients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine). | Procedure or surgery | No Antibiotic Arm, Topical antibiotic |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Hsu, MD principal investigator
Mid Atlantic Retina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conj flora Antibiotic resistance in people with Central Retinal Vein Occlusion and Choroidal Neovascularization, run by Mid Atlantic Retina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2012.