Retina Consultants of Delmarva
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.
3.1 Primary Objective To compare the acute post-injection IOP response between participants receiving prophylactic Iopidine and control participants receiving no pre-injection study medication. 3.2 Primary Endpoint Change in IOP from the immediately pre-injection measurement to the 1-minute post-injection measurement. 3.3 Secondary Objectives and Endpoints • IOP at 5, 15, and 30 minutes after injection. • Magnitude of peak post-injection IOP elevation. • Proportion of participants with clinically significant IOP elevations, including IOP ≥30 mmHg and IOP ≥40 mmHg. * Rate and time course of…
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 M…
One drop prior to intravitreal injection
Arctuva estimate
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