NCT00716586

Brief Summary

A small percentage of patients with retinal degeneration accumulate fluid in the center of their retina. Previous studies using an oral form of treatment has been successful in decreasing this fluid which improves vision. This study will test the use of a topically applied form of this treatment to the eye to reduce the amount of fluid and improve or preserve vision.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2015

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2017

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

October 15, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

9.9 years

First QC Date

July 14, 2008

Results QC Date

September 16, 2020

Last Update Submit

October 17, 2021

Conditions

Retinal Degenerations

Outcome Measures

Primary Outcomes (2)

  • Number of Participant With Improvement in Foveal Thickness (Macular Fluid) as Measured by Optical Coherence Tomography (OCT)

    Foveal thickness measured by OCT. A 17% or greater reduction in foveal thickness was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance with appointments. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.

    Baseline and most recent visit (2 month up to 36 months)

  • Number of Participants With Improvement in Macular Fluid as Measured Subjectively by Optical Coherence Tomography (OCT)

    Macular fluid measured subjectively by OCT. A 25% or greater reduction of macular fluid was considered an improvement. While initially it was our intent to follow participants at 1, 4, and 7 month intervals, these time periods could not be consistently adhered to based on participant non-compliance with appointments. Consequently, additional participants were subsequently seen at baseline to various time points beyond seven months that ranged from 2 months to 36 months at their most recent visit.

    Baseline and most recent visit (2 months up to 36 months)

Secondary Outcomes (1)

  • Number of Participants With Improvement of Seven Letters or More Read on a Visual Chart

    Baseline and most recent visit (2 months up to 36 months)

Study Arms (1)

Trusopt (2% dorzolamide)

EXPERIMENTAL

Intent to treat population. All participants assigned to Trusopt (2% dorzolamide)

Drug: 2% dorzolamide

Interventions

2% dorzolamideDRUG

Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)

Also known as: Trusopt
Trusopt (2% dorzolamide)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of cystic macular fluid on OCT testing

You may not qualify if:

  • Allergic reaction to sulpha containing compounds
  • Intolerance to dorzolamide (Trusopt)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Walia S, Fishman GA, Molday RS, Dyka FM, Kumar NM, Ehlinger MA, Stone EM. Relation of response to treatment with dorzolamide in X-linked retinoschisis to the mechanism of functional loss in retinoschisin. Am J Ophthalmol. 2009 Jan;147(1):111-115.e1. doi: 10.1016/j.ajo.2008.07.041. Epub 2008 Oct 2.

    PMID: 18834580DERIVED

MeSH Terms

Conditions

Retinal Degeneration

Interventions

dorzolamide

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal Diseases

Results Point of Contact

Title
Emeritus Professor of Ophthalmology
Organization
University of Illinois at Chicago
gerafish@uic.edu
312 997-3646

Study Officials

  • Gerald A Fishman, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emeritus Professor of Ophthalmology

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

October 1, 2005

Primary Completion

August 11, 2015

Study Completion

November 17, 2017

Last Updated

October 29, 2021

Results First Posted

October 15, 2021

Record last verified: 2021-10

Locations

US(1)