Not yet recruitingPhase 4

Iopidine to Decrease Intraocular Pressure Rise After Injections

Effect of Pre-Injection Iopidine on Intraocular Pressure and Transient Vision Loss Following High-Volume Intravitreal Injections

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The intravitreal injection is part of the participant's routine clinical care."
  • "Both groups will undergo post-injection IOP assessments at 5, 15, and 30 minutes post-injection and transient-vision-loss assessments."
  • "Both groups will undergo the additional standardized post-injection IOP assessments and transient-vision-loss assessments. 5\."
  • "The participant's treatment assignment will be documented in the study records. 7.2 Administration of Study Intervention For participants randomized to the Iopidine group, one drop of Iopidine 1% will be administered by a trained clinical technician approximately 20-30 minutes before the intravitreal injection."
  • "All participants will otherwise receive their clinically indicated intravitreal injection and undergo the same protocol-specified IOP assessments. 7.3 Masking This will be a fully unmasked (open label) study."
  • "To minimize potential measurement bias associated with the unmasked design, IOP will be obtained at prespecified standardized time points immediately before injection and at 1, 5, 15, and 30 minutes after injection, using the same standardized IOP measurement technique for both treatment groups."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether one Iopidine eye drop before an eye injection helps prevent a rise in eye pressure. It is for adults getting Eylea HD or Syfovre who have had brief vision loss after an eye injection before. Participants are assigned by chance to get Iopidine or no study medicine before the injection.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older and can give informed consent, meaning you understand and agree to join.
  • You are scheduled to get an Eylea HD or Syfovre injection inside your eye as part of your usual care.
  • You have had brief vision loss after an eye injection before.
  • You are willing and able to have eye pressure checks and complete the study tests.

Who can't join

  • You are allergic to apraclonidine, clonidine, or any ingredient in Iopidine, or you take or recently took an MAOI, a type of medicine.
  • You are pregnant or breastfeeding, unless the study doctor decides you may safely take part under the study rules.
  • The study doctor thinks serious heart or blood vessel disease, blood pressure problems, a slow heartbeat, fainting spells, or severe kidney or liver disease makes Iopidine too risky.
  • Your eye pressure is already too low, or you have an eye infection or major swelling in the study eye.
  • An eye condition or past eye surgery could make pressure checks unreliable or greatly change the pressure response, as judged by the study doctor.
  • You use Iopidine or another short-acting eye pressure medicine just before the injection that could affect the results, or your usual care requires medicine to prevent a pressure rise.
  • You cannot complete pressure checks at 1, 5, 15, and 30 minutes after the injection, or cannot or will not agree to join or follow study steps.
  • You are in another treatment study, or have another health condition, that the study doctor thinks could make this study unsafe or affect its tests or results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Participation in another interventional clinical trial that, in the investigator's judgment, could interfere with the safety assessments or interpretation of study outcomes. * Any medical, ocular, psychiatric, or other condition that, in the opinion of the investigator, would place the participant at unacceptable risk, interfere with study procedures, or compromise interpretation of the study results.

Study sites (1)

MD