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.

Age range18 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment
✕. Subjects with a history of ocular trauma of any type in the study eye
✕. Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye per the investigator's judgment

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

NCT IDNCT01966328

SponsorJeffrey S Heier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-10

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment
✕. Subjects with a history of ocular trauma of any type in the study eye
✕. Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye per the investigator's judgment