Neovascular Age-related Macular DegenerationPhase 4NCT03918590
Post Intravitreal Injection Topical NSAID vs. Patching
A Phase 4 study testing nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX), Theratears tear drop, (Akron, Ann 111 Arbor, MI) and patching in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by The New York Eye & Ear Infirmary at 1 site in United States.
Trial summary
A prospective randomized trial, to evaluate post-injection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- What is being tested?
- nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX), Theratears tear drop, (Akron, Ann 111 Arbor, MI) and patching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 3 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Already scheduled for anti-VEGF injection based on standard of care for disease process.
- Ability to provide written informed consent
- Capable of complying with study protocol.
- Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care
Who cannot join
- History of past intraocular injection of steroid medication.
- Experiencing baseline eye pain
- Monocular; non-study eye with VA<20/100.
- Unwilling or unable to follow or comply with all study related procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Eye and Ear Infirmary
New York, New York, 10003
About this study
Official title: Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pressure Patching: A Prospective, Randomized, Placebo Controlled Trial
A prospective randomized trial, to evaluate post-injection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching.
Read the detailed description
This is a single masked, randomized, placebo-controlled study that will enroll approximately 60 subjects with recent active retina related disease requiring intravitreal agents. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive nepafenac 0.3% suspension or a sham procedure. Subjects will have a one in three (33%) chance of receiving active treatment (no sham procedure), a one in three (33%) chance of receiving patching procedure (no active treatment) or a one in three (33%) chance of receiving placebo (no active treatment).
Study participants will then complete the Visual Analog Scale immediately following injection and then after 1 hour, and, 24 hours. The VAS data along with relevant data related to each subject's injection will also be compiled, including, but not limited to: drug injected, diagnosis, co-morbid conditions, history of previous injections, visual acuity, age, and gender.
- Conditions
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- Being tested
- nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX), Theratears tear drop, (Akron, Ann 111 Arbor, MI), patching
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)Drug
NSAID
Theratears tear drop, (Akron, Ann 111 Arbor, MI)Drug
preservative-free Artificial Tears
patchingOther
no drug/ patching
| Study group | Role | What they receive |
|---|---|---|
| A single drop of nepafenac 0.3% suspension | Active comparator | A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX) Receives: Drug: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX) |
| Patching | Other | A light pressure patch applied for two hours Receives: Other: patching |
| A single drop of preservative-free Artificial Tears | Placebo comparator | A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI). Receives: Drug: Theratears tear drop, (Akron, Ann 111 Arbor, MI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Intravitreal Injection Measurement of Pain
Change from Baseline post intravitreal injection pain at 6 and 24 hours as measured by the Numeric Pain Rating Scale. The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), at the screening, 6 hours and 24 hours.
Measured: 6 hours and 24 hours after intravitreal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start3 Dec 2018
- Primary completion1 May 2019 (estimated)
- Study completion3 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Placebo (Preservative free artificial tears) Group 2: Nepefanac 0.3% suspension Group 3: Patch for 2 hours
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New York Eye & Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Gentile, MD, The New York Eye & Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918590
- Sponsor's protocol ID
- 16.15
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pressure Patching: A Prospective, Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03918590
- Acronym / sponsor ID
- 16.15
- Conditions
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The New York Eye & Ear InfirmaryUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 3 Jun 2019 (estimated)
- First posted
- 17 Apr 2019 (actual)
- 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.
A prospective randomized trial, to evaluate post-injection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching.
Detailed description
This is a single masked, randomized, placebo-controlled study that will enroll approximately 60 subjects with recent active retina related disease requiring intravitreal agents. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive nepafenac 0.3% suspension or a sham procedure. Subjects will have a one in three (33%) chance of receiving active treatment (no sham procedure), a one in three (33%) chance of receiving patching procedure (no active treatment) or a one in three (33%) chance of receiving placebo (no active treatment).
Study participants will then complete the Visual Analog Scale immediately following injection and then after 1 hour, and, 24 hours. The VAS data along with relevant data related to each subject's injection will also be compiled, including, but not limited to: drug injected, diagnosis, co-morbid conditions, history of previous injections, visual acuity, age, and gender.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Group 1: Placebo (Preservative free artificial tears) Group 2: Nepefanac 0.3% suspension Group 3: Patch for 2 hours
| Arm | Type | Receives |
|---|---|---|
| A single drop of nepafenac 0.3% suspension | Active comparator | Drug: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX) |
| Patching | Other | Other: patchingA light pressure patch applied for two hours |
| A single drop of preservative-free Artificial Tears | Placebo comparator | Drug: Theratears tear drop, (Akron, Ann 111 Arbor, MI)A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Already scheduled for anti-VEGF injection based on standard of care for disease process.
- Ability to provide written informed consent
- Capable of complying with study protocol.
- Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care
Key exclusion criteria (4 listed)
- History of past intraocular injection of steroid medication.
- Experiencing baseline eye pain
- Monocular; non-study eye with VA<20/100.
- Unwilling or unable to follow or comply with all study related procedures
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 |
|---|---|---|
| nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)NSAID | Drug | A single drop of nepafenac 0.3% suspension |
| Theratears tear drop, (Akron, Ann 111 Arbor, MI)preservative-free Artificial Tears | Drug | A single drop of preservative-free Artificial Tears |
| patchingno drug/ patching | Other | Patching |
Primary outcome
Post Intravitreal Injection Measurement of Pain
Time frame: 6 hours and 24 hours after intravitreal injection
Change from Baseline post intravitreal injection pain at 6 and 24 hours as measured by the Numeric Pain Rating Scale. The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), at the screening, 6 hours and 24 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX), Theratears tear drop, (Akron, Ann 111 Arbor, MI) and patching in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by The New York Eye & Ear Infirmary 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 17 Apr 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Post Intravitreal Injection Measurement of Pain (time frame: 6 hours and 24 hours after intravitreal 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 17 Apr 2019.