Intravitreal Dexamethasone Implant in Retinitis Pigmentosa-related Macular Edema- a Retrospective Study

June 17, 2016 updated by: Ahmad Mansour, MD, Clinical Professor, AUB, Rafic Hariri University Hospital

Dexamethasone in Retinitis Pigmentosa Cystoid Macular Edema

Purpose: Cystoid macular edema (CME) in retinitis pigmentosa (RP) has been managed in several ways with little success. The aim of our study was to report the use of intravitreal dexamethasone implant in a large series of patients with RP and CME.

Setting: Retrospective case series. Methods: Cases were diagnosed as RP based on the classic fundus triad of bone-spicule pigment deposits (intraretinal pigmentary migration), retinal vessel attenuation, waxy pallor of the optic disc along with night blindness and attenuated ERG amplitudes (delays in rod or cone b-wave implicit times). Family history of RP and family screening for RP were important in establishing the diagnosis in eyes with some diagnostic challenge. CME was diagnosed by intravitreous fluorescein angiography IVFA and spectral domain optical coherence tomography (SD-OCT). BCVA was monitored using Snellen visual acuity chart and CME was monitored by SD-OCT on follow-up visits.

Study Overview

Status

Status

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

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

Introduction Retinitis pigmentosa (RP) is a group of inherited progressive retinal degenerations characterized by photoreceptor dysfunction primarily affecting the rods, followed by cones with worldwide prevalence of approximately one in 3,000-4,000 for a total of 2 million affected individuals all over the world. After rods die, cone photoreceptors gradually die resulting in constriction of visual fields and eventual blindness in many patients. There is presently no cure for RP where photoreceptor apoptosis plays a key role, but considerable effort is devoted to the search of rescue strategies. This condition can lead to blindness in the advanced stages of disease, when it involves the central retina. Also macular abnormalities appear frequently in RP leading to visual decline. CME is prevalent in 20-70% of RP patients and several treatment options were reported with variable success rates and with many side-effects. Therapies have included oral or topical carbonic anhydrase inhibitors, intravitreal VEGF antagonists, and periocular or intravitreal corticosteroids. The dexamethasone implant has been recently approved for the treatment of maculopathies related to diabetic retinopathy or retinal vein occlusion or uveitis. The current study explores the role of such implant in CME from RP.

Methods The investigators conducted a retrospective noncomparative study of the use of intravitreal dexamethasone implant in eyes with CME from RP. The study adhered to the tenets of the declaration of Helsinki. All patients signed an informed consent after detailed review of the benefits and complications of current therapy.

RP is defined as the presence of the triad of bone-spicule pigment deposits, retinal vessel attenuation and waxy pallor of the optic disc. Family history of RP, family screening for RP, and ERG recordings were ancillary tests in atypical RP. CME is defined as the presence of cystoid changes in the macula seen on linear scans by spectral domain OCT regardless of presence of retinal thickening (Gorovoy). Primary outcomes were best-corrected visual acuity and central macular thickness. Study duration was January 2012?? to December 2015 with all participants signing a formal consent. Inclusion criteria included naïve or previously treated CME. Exclusion criteria included diabetes mellitus, vitreous hemorrhage, macular ischemia, macular scar from subretinal fibrosis, corneal scar, infectious conjunctivitis, prior cataract or vitreous surgery, and inability to commit for long-term follow-up. Primary outcome measures included best-corrected visual acuity (BCVA) assessed by Snellen charts and central macular thickness (CMT, mean thickness in the central 1000-μm diameter area) using spectral domain optical coherence tomography (OCT). Intravenous fluorescein angiography was done at the initial exam using standard protocol with visualization of the retinal midperiphery. Comprehensive ocular examination including applanation tonometry was performed at baseline, and usually at month 1, months 2 and months 3 and thereafter. Ozurdex® (Allergan, Inc., Irvine, CA, USA) is an intravitreal rod shaped implant containing 0.7 mg dexamethasone in the Novadur® poly (D,L-lactide-co-glycolide solid polymer sustained-release drug delivery system. The implant was injected under sterile conditions using povidone iodine 5%, sterile lid speculum and topical anesthesia. Only one patient who was 9-year old received sedative agents in order to achieve patient cooperation. The single-use applicator was injected into the midvitreous through a self-sealing scleral injection 3,5 mm posterior to the limbus at the superotemporal or inferotemporal area. Genetic testing was not carried in the current case series.

Statistical analyses were done using SPSS version 22 (IBM Corporation, Chicago, Illinois) and Wilcoxon-Signed Rank Test with significance set at p-value of 0.05.

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 (Anticipated)

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.
50

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 2

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

12 years to 86 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Retinitis pigmentosa with cystoid macular edema -

Exclusion Criteria: infection, inability to consent, cataract, glaucoma, end-stage retinitis pigmentosa

-

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: Non-Randomized
  • Interventional Model: Single Group 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: therapy
Dexamethasone injection
Device: dexamethasone injection
intravitreal dexamethasone in retinitis pigmentosa cystoid macular edema
Other Names:
  • OZURDEX

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
visual gain measured as Snellen visual acuity
Time Frame: 4 months
logMAR improvement after ozurdex implant
4 months

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
resolution of macular edema by OCT
Time Frame: 4 months
OCT measurement of macular thickness
4 months

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.
Rafic Hariri University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ahmad mansour, md, RHUH

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.
January 1, 2015

Primary Completion (Anticipated)

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.
December 1, 2016

Study Completion (Anticipated)

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.
December 1, 2016

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).
May 18, 2016

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.
June 16, 2016

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.
June 17, 2016

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.
June 20, 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.
June 17, 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.
June 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.
  • INV-2016-267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

we can share data through excel sheet

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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