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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01966328
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : March 31, 2016
Sponsor:
Collaborator:
Kato Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jeffrey S Heier, Ophthalmic Consultants of Boston

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

Condition or disease Intervention/treatment Phase
Vitreomacular Attachment Vitreomacular Traction Vitreomacular Adhesion Drug: 36% Resolvine Intravitreal Injection Drug: 9% Resolvine Intravitreal Injection Phase 1

Detailed Description:
This research is studying the effect that Resolvine injection will have on patients with vitreomacular adhesion. The investigators propose that intravitreal injection of Resolvine® 36% will: 1)Result in release of the vitreous adhesion to the macula in subjects with symptomatic vitreomacular attachment (VMA). 2)The Release of the VMA will create a measurable and favorable retinal change. 3) The release of vitreomacular traction may also result in visual acuity improvement within the short time frame of this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment
Study Start Date : October 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: 36% Resolvine
Patients in this arm will be given one dose of 36% Resolvine intravitreal injection, with the possibility of a second dose at Day 30
Drug: 36% Resolvine Intravitreal Injection
36% Resolvine Intravitreal Injection

Active Comparator: 9% Resolvine
Patients in this arm will be given one dose of 9% Resolvine intravitreal injection, with the possibility of a second dose at Day 30
Drug: 9% Resolvine Intravitreal Injection
9% Resolvine Intravitreal Injection




Primary Outcome Measures :
  1. Safety of 36% Resolvine Injection versus 9% Resolvine Injection [ Time Frame: After all patients have completed the 6 month follow-up. ]
    The primary objective of this study is to evaluate the safety of an active arm treated with Resolvine® 36%, which may contain up to two 100-microliter intravitreal injections, in comparison to a control arm treated with Resolvine 9%, which may contain up to two 100-microliter injections, in subjects with VMA. Cumulative adverse event rates for each arm will be evaluated.

  2. Efficacy of 36% Resolvine Injection versus 9% Resolvine Injection [ Time Frame: After all patients have completed the 6 month follow-up ]
    The primary objective of this study is to evaluate the efficacy of an active arm treated with Resolvine® 36%, which may contain up to two 100-microliter intravitreal injections, in comparison to a control arm treated with Resolvine 9%, which may contain up to two 100-microliter injections, in subjects with VMA. Efficacy will be measured by the percent of patients whose VMA has released after treatment.


Secondary Outcome Measures :
  1. Inducement of PVD [ Time Frame: After all patients have completed the 6 month follow-up ]
    These analyses will compare the efficacy an active arm treated with Resolvine® 36%, which may contain up to two 100-microliter intravitreal injections, to a control arm treated with Resolvine 9%, which may contain up to two 100-microliter injections, to assess inducement of a more extensive PVD over the study period as demonstrated by Trese Grade III or higher B-Scan Ultrasound and OCT.

  2. Improved Eye Function [ Time Frame: After all patients have completed the 6 month follow-up. ]
    These analyses will assess a parameter of improved eye function as calculated by either the reduction in the retinal thickness of at least 10% over baseline at Day 0 as quantified by OCT, or an improvement in visual acuity of more than 10% over baseline at day 0 as quantified by ETDRS.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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)
  2. Subjects who have monocular vision or contralateral vision of 20/400 or worse BCVA in the non-study eye
  3. Subjects with a history of retinal detachment or tear in the study eye
  4. Subjects who have PVD in the study eye at Baseline (Grade III or greater PVD by B-scan)
  5. 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.
  6. Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment
  7. Subjects with a history of ocular trauma of any type in the study eye
  8. Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye per the investigator's judgment
  9. Subjects that have undergone any previous vitrectomy (either anterior or pars plana vitrectomy) in the study eye
  10. Subjects with a history of cataract surgery complications in the study eye
  11. Subjects that have undergone previous photocoagulation of the retina in the study eye
  12. Subjects with any evidence or history of either nonproliferative or proliferative diabetic retinopathy (NPDR) or (PDR) in the study eye
  13. Subjects with an anticipated need for cataract extraction in the study eye within the next 6 months
  14. Subjects with congenital eye malformations
  15. Subjects with recurrent uveitis or history of uveitis in either eye
  16. Subjects with ongoing ocular infection or inflammation in the study eye
  17. Subjects who are pregnant or nursing. Subjects of child bearing ages will undergo pregnancy testing.
  18. Subjects that are currently participating in any other investigational research study
  19. Subjects who are too ill to be likely to complete the entire study
  20. Subjects who have undergone major surgery within the last 6 months (systemic or ocular) or who are likely to require major surgery in the upcoming 6 months
  21. Subjects who are uncontrolled diabetics (HbA1/C > 10%) with significant morphological pathology at the time of enrollment
  22. Subjects with macular holes Stage 2 or greater as determined by OCT, B-scan ultrasound and clinical examination
  23. Subjects with epiretinal membrane (ERM) at the area of attachment as determined by OCT
  24. Subjects that have received other intravitreal injection therapy within thirty (30) days of treatment with Resolvine®
  25. Subjects that have received more than one Jetrea injection in the study eye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966328


Locations
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United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Jeffrey S Heier
Kato Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Jeffrey S Heier, MD Ophthalmic Consultants of Boston

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Responsible Party: Jeffrey S Heier, Sponsor-Investigator, Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier: NCT01966328     History of Changes
Other Study ID Numbers: VMA-001
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016