Povidone Iodine vs AVEnova: A Pre-injection Disinfection Study (PAVE Study)

NCT04018482 | Completed Phase 4 FDA Drug

• 1 other identifier: PAVE study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and comfort of two FDA approved pre-injection antiseptics when used for intravitreal injections.

Conditions

Age-related Macular Degeneration; Diabetic Retinopathy; Diabetic Macular Edema

Keywords

intravitreal; injection; disinfectant; comfort; Povidone Iodine; Avenova

Outcome Measures

Primary Outcomes (2)

• Comfort of Povidone Iodine vs Avenova immediately post-treatment based on an 11-point numerical scale (0-10, with 0 being no pain, and 10 being extreme pain)

  Reported comfort levels will be collected immediately after the injection procedure. Average reported comfort levels in the Povidone Iodine group will be compared with average reported comfort levels from the Avenova group at each time point using a paired Student's T-test.

  Immediately following the subject's injection.

• Comfort of Povidone Iodine vs Avenova 1-2 hours post treatment based on an 11-point numerical scale (0-10, with 0 being no pain, and 10 being extreme pain)

  Reported comfort levels will be collected 1-2 hours post-injection. Average reported comfort levels in the Povidone Iodine group will be compared with average reported comfort levels from the Avenova group at each time point using a paired Student's T-test.

  1-2 hours post-injection.

Secondary Outcomes (1)

• Change in colony forming unit (CFU) growth pre- and post-treatment with Povidone Iodine or Avenova to determine if Avenova is non-inferior to Povidone Iodine for ocular disinfection.

  Two time points: 30 seconds before disinfection starts (time point 0); and after the 10 minutes disinfection period and prior just prior to the injection (time point 1).

Study Arms (1)

Open label test arm

EXPERIMENTAL

Subjects will have their right eye treated with 5% Povidone Iodine per standard institutional protocol prior to receiving their intravitreal injection (2 drops of PI followed by application of 3.5% non-preserved lidocaine gel for 10 minutes, followed by 1 drop of PI for 30 seconds prior to injection). Subjects will have their left eye treated with Avenova per the same application protocol as PI prior to receiving their intravitreal injection. Prior to and following disinfecting both eyes but before the injection, a physician will gently swab the inferior conjunctival fornix (white part of each eye below the lower eye lid) with an ocular brush. Swabs will be cultured to compare bacterial counts. Subjects will be asked to complete a questionnaire regarding comfort of the disinfectant and injection procedure in general immediately following the injection and 1-2 hours post-injection.

Other: Povidone Iodine; Other: Hypochlorous Acid

Interventions

Povidone Iodine OTHER

FDA-approved disinfectant for intravitreal injections

Open label test arm

Hypochlorous Acid OTHER

FDA-approved disinfectant for intravitreal injections

Also known as: Avenova

Open label test arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be receiving same day bilateral injections of an anti-VEGF agent for any ophthalmic condition.
• Subject must be fluent in English.

You may not qualify if:

• Under 18 years old.
• Subjects with an allergy or adverse reaction to Povidone Iodine or Avenova.

Sponsors & Collaborators

• California Retina Consultants: lead

Study Sites (1)

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy

Interventions

Povidone-Iodine; Hypochlorous Acid

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Acids, Noncarboxylic; Acids; Chlorine Compounds; Reactive Oxygen Species; Free Radicals; Oxides; Oxygen Compounds

Study Officials

• Robert Avery, MD

  California Retina Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single cohort will have one eye (right) treated with Povidone Iodine (PI), and one eye (left) treated with Avenova.

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 12, 2019
• Study Start: July 16, 2019
• Primary Completion: August 14, 2019
• Study Completion: August 14, 2019
• Last Updated: March 10, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)