Age Related Macular DegenerationNCT03038048
30g vs 33g Needle for Intravitreal Injections
A study testing Varying needle size with intravitreal ranibizumab or aflibercept in people with Age Related Macular Degeneration and Diabetic Macular Edema, run by Wills Eye at 1 site in United States.
Trial summary
We are comparing the patient experience between the standard 30 g needle to the smaller 33 g needle for intravitreal injections of ranabizumab or aflibercept for age related macular degeneration, diabetic macular edema, or retina vein occlusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- What is being tested?
- Varying needle size with intravitreal ranibizumab or aflibercept
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2017to 27 Apr 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing bilateral, same-day, intravitreal injections of either ranibizumab oraflibercept for the diagnosis of wet AMD, DME, or RVO-associated macular edema
Who cannot join
- 1) Patients who do not receive Betadine ophthalmic solution prior to intravitreal injection due to documented allergy 2) Patients who are receiving intravitreal bevacizumab (this medication iscompounded into pre-filled 1-mL tuberculin syringes).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mid Atlantic Retina- Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Intravitreal Injection Using 33-gauge Versus 30-gauge Needles: Comparison of Patients' Experience
We are comparing the patient experience between the standard 30 g needle to the smaller 33 g needle for intravitreal injections of ranabizumab or aflibercept for age related macular degeneration, diabetic macular edema, or retina vein occlusions.
Read the detailed description
This is a prospective, randomized, interventional pilot study, which seeks to compare the patient experience using 30-gauge versus 33-gauge needle for bilateral same-day intravitreal injections of ranibizumab or aflibercept for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), or macular edema associated with retinal vein occlusion (RVO). The null hypothesis is that there is no difference in patient discomfort or pain with the 30-gauge needle compared to the 33-gauge needle.
- Being tested
- Varying needle size with intravitreal ranibizumab or aflibercept
- Medical subject headings
- Macular Degeneration, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varying needle size with intravitreal ranibizumab or afliberceptProcedure or surgery
Also called Lucentis, Eylea
Varying gauge of needle, 33 gauge vs 30 gauge
| Study group | Role | What they receive |
|---|---|---|
| 33 g needle - right eye | Experimental | 33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye Receives: Procedure: Varying needle size with intravitreal ranibizumab or aflibercept |
| 33 g needle - left eye | Experimental | 33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye Receives: Procedure: Varying needle size with intravitreal ranibizumab or aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in discomfort between 30g and 33g needle
Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections
Measured: Day 1
Secondary outcomes (1)
Intraocular pressure 5 minutes post injection
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start27 Jan 2017
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Mid Atlantic Retina
- Responsible party
- Principal investigator, MidAtlantic Retina, Wills Eye
- Investigators
- Allen Chiang, MD, Principal investigator, Mid Atlantic Retina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038048
- Sponsor's protocol ID
- 16-594E
- Status last verified
- Jul 2017
- First submitted
- 27 Jan 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Injection Using 33-gauge Versus 30-gauge Needles: Comparison of Patients' Experience
- ClinicalTrials.gov ID
- NCT03038048
- Acronym / sponsor ID
- 16-594E
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Mid Atlantic Retina
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 31 Jan 2017 (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.
We are comparing the patient experience between the standard 30 g needle to the smaller 33 g needle for intravitreal injections of ranabizumab or aflibercept for age related macular degeneration, diabetic macular edema, or retina vein occlusions.
Detailed description
This is a prospective, randomized, interventional pilot study, which seeks to compare the patient experience using 30-gauge versus 33-gauge needle for bilateral same-day intravitreal injections of ranibizumab or aflibercept for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), or macular edema associated with retinal vein occlusion (RVO). The null hypothesis is that there is no difference in patient discomfort or pain with the 30-gauge needle compared to the 33-gauge needle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 33 g needle - right eye | Experimental | Procedure: Varying needle size with intravitreal ranibizumab or aflibercept33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye |
| 33 g needle - left eye | Experimental | Procedure: Varying needle size with intravitreal ranibizumab or aflibercept33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing bilateral, same-day, intravitreal injections of either ranibizumab oraflibercept for the diagnosis of wet AMD, DME, or RVO-associated macular edema
Key exclusion criteria (1 listed)
- 1) Patients who do not receive Betadine ophthalmic solution prior to intravitreal injection due to documented allergy 2) Patients who are receiving intravitreal bevacizumab (this medication iscompounded into pre-filled 1-mL tuberculin syringes).
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 |
|---|---|---|
| Varying needle size with intravitreal ranibizumab or afliberceptAlso: Lucentis, EyleaVarying gauge of needle, 33 gauge vs 30 gauge | Procedure or surgery | 33 g needle - left eye, 33 g needle - right eye |
Primary outcome
Difference in discomfort between 30g and 33g needle
Time frame: Day 1
Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections
1 secondary outcome
Intraocular pressure 5 minutes post injection
Time frame: Day 1
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 25 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Allen Chiang, 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 Varying needle size with intravitreal ranibizumab or aflibercept in people with Age Related Macular Degeneration and Diabetic Macular Edema, run by Wills Eye 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 25 Jul 2017. 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?
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?
Difference in discomfort between 30g and 33g needle (time frame: Day 1). 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 25 Jul 2017.