Interval Intraocular Pressure in Intravitreal Injection Study

NCT04868175 | Completed DMC

• 1 other identifier: IIII
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study of IOP in Intravitreal injections to evaluate:

1. 1.IOP effect of intravitreal injection
2. 2.IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose) over multiple time periods
3. 3.IOP response in correlation to number of injections, IOL, type of anti VEGF, co morbidities

Conditions

Glaucoma; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• IOP effect of prophylactic IOP lowering eye drops over multiple time points

  IOP in mmHg

  From baseline to 30 minutes after injection

Secondary Outcomes (3)

• IOP effect of intravitreal injection

  From baseline to 30 minutes after injection

• IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities

  From baseline to 30 minutes after injection

• Inflammation to types of anti VEGF

  1 week post injection

Study Arms (3)

Group 1

ACTIVE COMPARATOR

control (hypromellose), then Timolol, then Travatan

Drug: Timolol; Drug: Travatan; Drug: Hypromellose

Group 2

ACTIVE COMPARATOR

Timolol, then Travatan, Hypromellose

Drug: Timolol; Drug: Travatan; Drug: Hypromellose

Group 3

ACTIVE COMPARATOR

Travatan, then Hypromellose, Timolol

Drug: Timolol; Drug: Travatan; Drug: Hypromellose

Interventions

Timolol DRUG

Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production

Group 1; Group 2; Group 3

Travatan DRUG

Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow

Group 1; Group 2; Group 3

Hypromellose DRUG

Placebo eye drop, lubricant

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AMD patients requiring multiple intravitreal injections (Eylea or Lucentis), not necessarily 3 month loading.
• Age \>50
• Chinese patients with ability to read Chinese ICF

You may not qualify if:

• Known glaucoma
• Corneal disease e.g. corneal scarring or opacity preventing fundal view
• On steroid or anti glaucoma eye drops
• Prior vitrectomy or glaucoma surgery
• Recent intraocular surgery i.e. cataracts surgery
• Pseudophakic with anterior chamber IOL
• History of ocular inflammatory disease e.g. uveitis
• Previous laser iridotomy
• Recent intravitreal injection of steroid
• Inability for regular follow-up

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

HKSDS Program

Hong Kong, 000000, Hong Kong

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Timolol; Travoprost; Hypromellose Derivatives

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Cellulose; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients are not exposed to the eye drop bottle (taped) and the doctors measuring pressure and performing the intravitreal injections are not shown the eye drops given
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan, Hypromellose Group 3: Travatan, then Hypromellose, Timolol There are three groups of different treatments. Patients recruited will undergone all three groups of treatments. During the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. Treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly. Injection doctors masked to treatments given.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 30, 2021
• Study Start: October 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

HK (1)