Iopidine to Decrease Intraocular Pressure Rise After Injections

NCT07891910 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 20263247
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, controlled, open-label, single-site investigator-initiated clinical trial. A total of 120 participants will be randomized in a 1:1 ratio either to receive one drop of apraclonidine 1% ophthalmic solution (Iopidine) approximately 20-30 minutes before a clinically indicated intravitreal injection of Eylea HD or Syfovre, or to a control group that will receive no pre-injection study medication. The intravitreal injection is part of the participant's routine clinical care. The research-specific intervention for participants assigned to the Iopidine group is administration of Iopidine. Participants assigned to the control group will receive no pre-injection study medication. Both groups will undergo post-injection IOP assessments at 5, 15, and 30 minutes post-injection and transient-vision-loss assessments.

Conditions

Macular Degeneration; Diabetic Retinopathy; Retinal Vein Occlusion; Glaucoma

Keywords

Intravitreal injection; Intraocular pressure; Iopidine; Transient vision loss; macular degeneration; glaucoma; diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure one minute after injection

  12 weeks

Secondary Outcomes (2)

• IOP at 5, 15, 30 minutes after injection

  12 weeks

• Transient vision loss

  12 weeks

Study Arms (2)

Iopidine

ACTIVE COMPARATOR

Patients receiving the Iopidine prior to injection

Drug: Apraclonidine 1.0% ophthalmic solution

Comparator

NO INTERVENTION

Patients not receiving Iopidine

Interventions

Apraclonidine 1.0% ophthalmic solution DRUG

One drop prior to intravitreal injection

Iopidine

Eligibility Criteria

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

You may qualify if:

• Adult patient able to provide informed consent.
• Scheduled to receive a clinically indicated intravitreal injection with Eylea HD or Syfovre.
• Reports a prior history of transient vision loss following intravitreal injection.
• Willing and able to undergo study-specific IOP measurements and complete study assessments.

You may not qualify if:

• Known hypersensitivity or prior clinically significant allergic reaction to apraclonidine, clonidine, or any component of Iopidine 1% ophthalmic solution.
• Current treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within a clinically relevant washout period before enrollment.
• Age younger than 18 years.
• Pregnancy or breastfeeding, if applicable, unless the investigator determines participation is appropriate based on available safety information and applicable regulatory requirements.
• Severe or unstable cardiovascular disease that, in the judgment of the investigator, could increase the risk associated with apraclonidine, including unstable coronary artery disease, recent myocardial infarction, clinically significant bradycardia, symptomatic hypotension, uncontrolled hypertension, or clinically significant cerebrovascular disease.
• History of clinically significant vasovagal episodes, syncope, or symptomatic hypotension that, in the investigator's judgment, would increase the risk of apraclonidine administration.
• Severe renal or hepatic impairment when, in the investigator's judgment, systemic exposure to apraclonidine could pose increased risk.
• Baseline IOP sufficiently low that additional pharmacologic IOP reduction could pose a clinical risk, as determined by the investigator.
• Active ocular infection or significant ocular inflammation in the study eye at the time of the planned intravitreal injection.
• Any ocular condition that would prevent reliable IOP measurement or substantially confound assessment of the post-injection IOP response.
• Prior glaucoma surgery or other ocular surgery that, in the investigator's judgment, would substantially alter the expected acute IOP response to intravitreal injection, if such patients are not intended to be included in the study population.
• Use of apraclonidine or another short-acting IOP-lowering medication immediately before the study injection when such treatment could materially confound the study endpoint.
• Requirement for prophylactic IOP-lowering treatment before intravitreal injection as part of the patient's usual clinical care, such that assignment to the control group without prophylactic IOP-lowering medication would not be clinically appropriate.
• Inability to complete the required IOP measurements at 1, 5, 15, and 30 minutes after injection.
• Inability or unwillingness to provide informed consent or comply with study procedures.

Sponsors & Collaborators

• Retina Consultants of Delmarva: lead

Study Sites (1)

Retina Consultants of Delmarva

Easton, Maryland, 21601, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy; Retinal Vein Occlusion; Glaucoma

Interventions

apraclonidine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Ocular Hypertension

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Central Study Contacts

Travis J Peck, MD

CONTACT

410-546-8037; tpeck@delmarvaretina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)