Intravitreal Injection PatientsPhase 4NCT00690313
Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections
A Phase 4 study testing Vigamox in people with Intravitreal Injection Patients, run by Illinois Retina Associates at 1 site in United States.
Trial summary
Antibiotic eye drops are being used before and after intravitreal injections. Currently there is no study indicating the benefit of there usage or their dosage. In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior to the injection versus 1 day prior to intravitreal injection. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Intravitreal Injection Patients
- What is being tested?
- Vigamox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2011
- Phase
- Phase 4
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who need intravitreal injections patients who are willing to participate in the study
Who cannot join
- Patients who are allergic to Vigamox or who have taken any eye drops within the past 3 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Efficacy of Topical Vigamox Eye Drops at Tid 3 Days Prior to Intravitreal Injection Versus Tid 1 Day Prior to Intravitreal Injection
Antibiotic eye drops are being used before and after intravitreal injections. Currently there is no study indicating the benefit of there usage or their dosage.
In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior to the injection versus 1 day prior to intravitreal injection.
- Conditions
- Intravitreal Injection Patients
- Being tested
- Vigamox
- Keywords
- Vigamox, topical antibiotics, Intravitreal injections, macular degeneration, endophthalmitis
- Medical subject headings
- Macular Degeneration, Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VigamoxDrug
eye drops 3 times day either 1 or 3 days prior to intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Arm 1: receives Vigamox eye drops 3Xday for 3 days prior to intravitreal injection Receives: Drug: Vigamox |
| Arm 2 | Active comparator | Arm 2: receives Vigamox eye drops 3Xday for 1 day prior to intravitreal injection Receives: Drug: Vigamox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravitreal Injection PatientsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illinois Retina Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Kourous A Rezaei, MD, Principal investigator, Illinois Retina Associates SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690313
- Sponsor's protocol ID
- Vig508
- Status last verified
- Aug 2019
- First submitted
- 30 May 2008
- Last updated
- 7 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Efficacy of Topical Vigamox Eye Drops at Tid 3 Days Prior to Intravitreal Injection Versus Tid 1 Day Prior to Intravitreal Injection
- ClinicalTrials.gov ID
- NCT00690313
- Acronym / sponsor ID
- Vig508
- Conditions
- Intravitreal Injection Patients
- Keywords
- Vigamox, topical antibiotics, Intravitreal injections, macular degeneration, endophthalmitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Illinois Retina AssociatesUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Aug 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Jun 2008 (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.
Antibiotic eye drops are being used before and after intravitreal injections. Currently there is no study indicating the benefit of there usage or their dosage.
In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior to the injection versus 1 day prior to intravitreal injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: VigamoxArm 1: receives Vigamox eye drops 3Xday for 3 days prior to intravitreal injection |
| Arm 2 | Active comparator | Drug: VigamoxArm 2: receives Vigamox eye drops 3Xday for 1 day prior to intravitreal injection |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who need intravitreal injections patients who are willing to participate in the study
Key exclusion criteria (1 listed)
- Patients who are allergic to Vigamox or who have taken any eye drops within the past 3 weeks
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 |
|---|---|---|
| Vigamoxeye drops 3 times day either 1 or 3 days prior to intravitreal injection | Drug | Arm 1, Arm 2 |
Primary outcome
Timed study
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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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.
Kourous A Rezaei, MD principal investigator
Illinois Retina Associates SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vigamox in people with Intravitreal Injection Patients, run by Illinois Retina Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed study (time frame: 1 year). 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 7 Aug 2019.