PainEarly Phase 1NCT02142114
Assessment of Comfort Level Following an Intravitreal Injection by 30 or 32 Gauge Needles
A Early Phase 1 study testing Eye injection by 30 or 32 gauge needle in people with Pain, run by Retina Health Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if a smaller needle size reduces discomfort suffered by patients both during and following intravitreal injections. It is the investigators belief that using a smaller size needle will help patients to be less fearful of intravitreal injections and more amenable to treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Eye injection by 30 or 32 gauge needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 2016
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Subject's normal therapeutic regimen calls for them to receive two sessions of bilateral injections of the same volume of ranibizumab within the next year.
- Disease related considerations: None.
- Other considerations: Subjects who must be able to report pain scores during and up to 48 hours following an intravitreal injection. Also, subjects must consent to at least 5 intraocular pressure checks per eye for each injection procedure.
Who cannot join
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- special classes of subjects (vulnerable subjects), such as fetuses, pregnant women, children, institutionalized mentally disabled, or others, especially those whose ability to give voluntary informed consent may be in question.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Retina Health Center
Fort Myers, Florida, 33907
Gabriel M Gordon, Ph.D., 805-895-6666, gabrielmgordon@gmail.com
Alexander M Eaton, M.D.
About this study
The purpose of this study is to determine if a smaller needle size reduces discomfort suffered by patients both during and following intravitreal injections. It is the investigators belief that using a smaller size needle will help patients to be less fearful of intravitreal injections and more amenable to treatment. This study will also evaluate the effect of needle size on post injection intraocular pressure, to see if smaller needles may reduce wound leak and increase the intraocular pressure following injection.
The investigators hypothesize that subject eyes injected with the smaller size needle will result in greater patient comfort both during and after their injection as compared to the eye injected with the larger needle. The investigators objective is to reduce any discomfort felt by patients who receive intravitreal injections. The investigators also hypothesize that the smaller needle will result in higher post injection pressures, and another objective is to determine if this can affect patient comfort and increase the risk of glaucomatous optic nerve damage.
- Conditions
- Pain
- Being tested
- Eye injection by 30 or 32 gauge needle
- Keywords
- Intravitreal injection, Needle size, Pain, Intraocular pressure, Pain following an Intravitreal injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye injection by 30 or 32 gauge needleDevice
Consented patients receiving monthly bi-lateral injections of the same dose of ranibizumab will have one eye injected with a 30 gauge needle and the other eye injected with a 32 gauge needle. Bi-lateral injections may be performed on the same day or with one week of each other, depending on the subject preference and their normal injection regimen. On the first visit following enrollment in the study, the eye to receive the injection from the 30 or 32 gauge needle will be determined randomly. The other eye will be injected with the other needle size. When the patient returns for their next set of bi-lateral injections, the eyes receiving the 30 and 32 gauge needle injection will switch.
| Study group | Role | What they receive |
|---|---|---|
| Eye injection by 30 gauge needle | Active comparator | Consented patients receiving monthly bi-lateral injections of the same dose of ranibizumab will have one eye injected with a 30 gauge needle and the other eye injected with a 32 gauge needle. Bi-lateral injections may be performed on the same day or with one week of each other, depending on the subject preference and their normal injection regimen. On the first visit following enrollment in the study, the eye to receive the injection from the 30 or 32 gauge needle will be determined randomly. The other eye will be injected with the other needle size (may be that day or within 1 week of the 1st injection). When the patient returns for their next set of bi-lateral injections, the eyes receiving the 30 and 32 gauge needle injection will switch. Receives: Device: Eye injection by 30 or 32 gauge needle |
| Eye injection by 32 gauge needle | Active comparator | Not described Receives: Device: Eye injection by 30 or 32 gauge needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment.
Following each session of injections, the patient will be asked to fill out a short questionnaire regarding the comfort levels of the two needle sizes. Also, all subjects will be followed up by phone within 48 hours to assess any post-injection pain.
Measured: Immediately following an injection and follow-up within 48 hours of the injection.
Secondary outcomes (1)
Intraocular pressure assessment
As a secondary end point, pre and post injection intraocular pressure measurements will also be taken prior to each intravitreal injection by tonopen, as well as at 1-, 3-, 10-, and 30- minutes post-Intravitreal injection.
Measured: 1 minute prior, as well as 1, 3, 10, and 30 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Health Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Retina Consultants, Genentech, Inc.
- Responsible party
- Principal investigator, Alexander Eaton, Retina Health Center
- Investigators
- Alexander M Eaton, M.D., Principal investigator, Retina Health CenterGabriel M Gordon, Ph.D., Study director, Retina Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142114
- Sponsor's protocol ID
- ML29182
- Status last verified
- Dec 2015
- First submitted
- 12 May 2014
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Comfort Level Following an Intravitreal Injection by 30 or 32 Gauge Needles
- ClinicalTrials.gov ID
- NCT02142114
- Acronym / sponsor ID
- ML29182
- Conditions
- Pain
- Keywords
- Intravitreal injection, Needle size, Pain, Intraocular pressure, Pain following an Intravitreal injection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Retina Health CenterIndustry (pharma, biotech, devices)
- Collaborators
- California Retina Consultants, Genentech, Inc.
- Study start
- May 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 20 May 2014 (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.
The purpose of this study is to determine if a smaller needle size reduces discomfort suffered by patients both during and following intravitreal injections. It is the investigators belief that using a smaller size needle will help patients to be less fearful of intravitreal injections and more amenable to treatment. This study will also evaluate the effect of needle size on post injection intraocular pressure, to see if smaller needles may reduce wound leak and increase the intraocular pressure following injection.
The investigators hypothesize that subject eyes injected with the smaller size needle will result in greater patient comfort both during and after their injection as compared to the eye injected with the larger needle. The investigators objective is to reduce any discomfort felt by patients who receive intravitreal injections. The investigators also hypothesize that the smaller needle will result in higher post injection pressures, and another objective is to determine if this can affect patient comfort and increase the risk of glaucomatous optic nerve damage.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye injection by 30 gauge needle | Active comparator | Device: Eye injection by 30 or 32 gauge needleConsented patients receiving monthly bi-lateral injections of the same dose of ranibizumab will have one eye injected with a 30 gauge needle and the other eye injected with a 32 gauge needle. Bi-lateral injections may be performed on the same day or with one week of each other, depending on the subject preference and their normal injection regimen. On the first visit following enrollment in the study, the eye to receive the injection from the 30 or 32 gauge needle will be determined randomly. The other eye will be injected with the other needle size (may be that day or within 1 week of the 1st injection). When the patient returns for their next set of bi-lateral injections, the eyes receiving the 30 and 32 gauge needle injection will switch. |
| Eye injection by 32 gauge needle | Active comparator | Device: Eye injection by 30 or 32 gauge needle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
Key exclusion criteria (4 listed)
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- special classes of subjects (vulnerable subjects), such as fetuses, pregnant women, children, institutionalized mentally disabled, or others, especially those whose ability to give voluntary informed consent may be in question.
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 |
|---|---|---|
| Eye injection by 30 or 32 gauge needleConsented patients receiving monthly bi-lateral injections of the same dose of ranibizumab will have one eye injected with a 30 gauge needle and the other eye injected with a 32 gauge needle. Bi-lateral injections may be performed on the same day or with one week of each other, depending on the subject preference and their normal injection regimen. On the first visit following enrollment in the study, the eye to receive the injection from the 30 or 32 gauge needle will be determined randomly. The other eye will be injected with the other needle size. When the patient returns for their next set of bi-lateral injections, the eyes receiving the 30 and 32 gauge needle injection will switch. | Device | Eye injection by 30 gauge needle, Eye injection by 32 gauge needle |
Primary outcome
Pain assessment.
Time frame: Immediately following an injection and follow-up within 48 hours of the injection.
Following each session of injections, the patient will be asked to fill out a short questionnaire regarding the comfort levels of the two needle sizes. Also, all subjects will be followed up by phone within 48 hours to assess any post-injection pain.
1 secondary outcome
Intraocular pressure assessment
Time frame: 1 minute prior, as well as 1, 3, 10, and 30 minutes post-injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
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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.
Alexander M Eaton, M.D. principal investigator
Retina Health Center
Gabriel M Gordon, Ph.D. study director
Retina Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Eye injection by 30 or 32 gauge needle in people with Pain, run by Retina Health Center 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Dec 2015. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Gabriel M Gordon, Ph.D. (805-895-6666, gabrielmgordon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment. (time frame: Immediately following an injection and follow-up within 48 hours of the injection.). 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 21 Dec 2015.