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

March 29, 2016 updated by: Jeffrey S Heier
This research is studying the effect that Resolvine injection will have on patients with vitreomacular adhesion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After all patients have completed the 6 month follow-up.
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.
After all patients have completed the 6 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
After all patients have completed the 6 month follow-up
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.
After all patients have completed the 6 month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jeffrey S Heier

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kato Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VMA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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