CompletedPhase 1

A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment

United States21 participantsStarted 2013-10

Plain-language summary

This research is studying the effect that Resolvine injection will have on patients with vitreomacular adhesion.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female subjects, 18 years of age or older
. Willing and able to return for all study visits
. Willing and able to provide written informed consent
. Have symptomatic VMA.
. If both eyes are found to have Anatomic VMA the eye with lower visual acuity will be declared the study eye.

Exclusion criteria

. Subjects with high myopia in the study eye (axial length greater than or equal to 26.0 millimeters by ultrasound or spherical equivalent at the spectacle plane greater than -8.0 diopters)
. Subjects who have monocular vision or contralateral vision of 20/400 or worse BCVA in the non-study eye
. Subjects with a history of retinal detachment or tear in the study eye
. Subjects who have PVD in the study eye at Baseline (Grade III or greater PVD by B-scan)
. Subjects with unstable IOP (i.e. \> 30 mmHg in the past six months) or IOP of \> 21 mm Hg at enrollment, under medical control. Subjects may be on topical medications to control their IOP but may not stop or start a prostaglandin type or epinephrine based drug during the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety of 36% Resolvine Injection versus 9% Resolvine Injection

Timeframe: After all patients have completed the 6 month follow-up.

Efficacy of 36% Resolvine Injection versus 9% Resolvine Injection

Timeframe: After all patients have completed the 6 month follow-up

Trial details

NCT IDNCT01966328

SponsorJeffrey S Heier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10

View on ClinicalTrials.gov More Vitreomacular Attachment trials