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Nonsteroidal Anti-inflammatory Drug
Post Intravitreal Injection Topical NSAID vs. Patching
Phase 4
Waitlist Available
Research Sponsored by The New York Eye & Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours and 24 hours after intravitreal injection
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Drug Has Already Been Approved
Summary
A prospective randomized trial, to evaluate post-injection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching.
Eligible Conditions
- Diabetic Macular Edema
- Retinal Vein Occlusion
- Central Retinal Vein Occlusion
- Macular Degeneration
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 hours and 24 hours after intravitreal injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours and 24 hours after intravitreal injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post Intravitreal Injection Measurement of Pain
Side effects data
From 2009 Phase 2 trial • 33 Patients • NCT0078967218%
Headache
18%
Rash
18%
Cold/Upper Respiratory Infection/Cough
12%
Stomache Ache
6%
Muscle Pain
6%
Finger injury
6%
Pulled Muscle
6%
Flu
6%
Nausea/Vomiting
6%
Fatique/Sleepiness
6%
Conjunctivitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Higher Dose 0.76 mg Levodopa/Carbidopa
Lower Dose 0.51 mg Levodopa/Carbidopa
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: PatchingExperimental Treatment1 Intervention
A light pressure patch applied for two hours
Group II: A single drop of nepafenac 0.3% suspensionActive Control1 Intervention
A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
Group III: A single drop of preservative-free Artificial TearsPlacebo Group1 Intervention
A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI).
Find a Location
Who is running the clinical trial?
The New York Eye & Ear InfirmaryLead Sponsor
24 Previous Clinical Trials
3,265 Total Patients Enrolled