CLINICAL TRIAL

hRPC for Retinitis Pigmentosa

Waitlist Available · 18+ · All Sexes · Portland, OR

Safety and Tolerability of hRPC in Retinitis Pigmentosa

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About the trial for Retinitis Pigmentosa

Eligible Conditions
Retinitis · Retinitis Pigmentosa

Treatment Groups

This trial involves 2 different treatments. HRPC is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
hRPC
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The subject has the ability to consent to the study by providing a written signature on the consent form. show original
You must be an adult male or female over 18 years of age. show original
Study subjects must have a corrected ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity of 35 letters or less in the study eye for cohorts 1-5, a corrected ETDRS visual acuity of 63 letters (approximately 20/63) to 36letters (approximately 20/200) in the study eye for cohorts 6-8, and a corrected ETDRS visual acuity of 8 letters (approximately 20/800) to 68 letters (approximately 20/50) for cohorts 9 and on. show original
The test should be able to be completed without difficulty, and the patient's fixation and consistency between readings should be consistent enough to allow for the accurate detection of changes in retinal sensitivity. show original
You must be medically able to undergo a surgical procedure to remove the vitreous gel from your eye and an injection into the space below your retina. show original
The patient's serum chemistry and hematology are normal show original
There is no history of cancer in other parts of the body, except for some cases of non-melanoma skin cancer show original
This person has negative serology for human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), meaning that they have not been infected with any of these viruses. show original
The person is fit enough to have surgery that may require general anesthesia, as well as to undergo a short course of systemic corticosteroid therapy. show original
People who have RP have a clinical diagnosis based on one or more of the following: clinical features, medical imaging, electrophysiological measures and genetic testing, if available show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 months.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether hRPC will improve 1 primary outcome and 6 secondary outcomes in patients with Retinitis Pigmentosa. Measurement will happen over the course of 6 months.

Safety over the six months after treatment as assessed by the incidence of treatment emergent adverse events (TEAEs) and changes from baseline in other safety parameters.
6 MONTHS
Safety measures will be assessed by review of important events, including but not limited to inflammation, complications of the surgical procedure and worsening of vision.
6 MONTHS
Safety (Anatomical endpoint relating to retinal function in implant location - Color Fundus Photography)
24 MONTHS
A qualitative description of the change in retinal appearance of treated and untreated retinal area in the treated eye from baseline to end of study presented by treatment group.
24 MONTHS
Safety (Visual function measure: change in visual field: Goldmann visual field, microperimetry and FST)
24 MONTHS
A summary of the perimetry and change from baseline to end of study in the treated eye presented by treatment group.
24 MONTHS
Safety (Anatomical endpoint relating to retinal function in implant location - Fundus autofluorescence)
24 MONTHS
A qualitative description of the change in retinal appearance of treated and untreated retinal area in the treated eye from baseline to end of study presented by treatment group.
24 MONTHS
Safety (Change in retinal sensitivity in the area overlying the implanted hRPC as compared with untreated retina)
24 MONTHS
ERG results and change from baseline to end of study summarized descriptively and presented by treatment group.
24 MONTHS
Safety (Visual function measure: change in visual acuity)
24 MONTHS
A summary of the ETDRS +/- BRVT BCVA letter score and the change from baseline to end of study in the treated eye presented by treatment group.
24 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can retinitis pigmentosa be cured?

Retinitis pigmentosa can be prevented and/or treated, with no cure or complete treatment available. Early involvement, timely recognition, and adequate treatment will assist most patients to achieve a good functional outcome.

Anonymous Patient Answer

What are the signs of retinitis pigmentosa?

The signs and symptoms of retinitis pigmentosa are similar in both autosomal recessive and autosomal dominant forms of the disease. Those with X-linked retinitis pigmentosa may have mild or no symptoms at all, and the symptoms of autosomal dominant retinitis pigmentosa appear after about 2 decades of disease.

Anonymous Patient Answer

What is retinitis pigmentosa?

This form of congenital macular degeneration exhibits an autosomal recessive mode of inheritance. A common presentation is a loss of photopigment function resulting in the onset of vision loss in early childhood. Visual impairment can result in severe loss of quality of life for afflicted individuals and their families.

Anonymous Patient Answer

What are common treatments for retinitis pigmentosa?

Retinitis pigmentosa is a group of inherited degenerative eye diseases that affect the light-sensing cells in the retina, often causing vision loss early in life. Retinitis pigmentosa may be managed by using prosthesis, cataract surgery, or in some cases by gene therapy. The prostheses currently used to treat retinitis pigmentosa include contact lenses, intraocular lenses, and photoreactive ocular prosthetics. Cataract surgery and contact lens treatment may be used to treat a number of cataracts, which are a result of age-related crystalline lens opacities.

Anonymous Patient Answer

How many people get retinitis pigmentosa a year in the United States?

About 50,000 people are diagnosed with retinitis pigmentosa a year in the United States, making it the second most common form of inherited blindness before all age groups.

Anonymous Patient Answer

What causes retinitis pigmentosa?

We found a significantly increased age of onset of RP, especially in females. A significant association was also found for RP-retinopathy in the family history of RP patients, particularly among male patients. Findings from a recent study support the notion that environmental and genetic factors interact in age of onset of RP.

Anonymous Patient Answer

How serious can retinitis pigmentosa be?

RP occurs at a very young age and can cause major changes to one's life. In a study of patients with uncomplicated and early localized RP, those diagnosed from birth to age 11 had a significantly lower IOP than did patients with late RP. The IOP, however, was still abnormal and should be followed by frequent visits to the eye.

Anonymous Patient Answer

Does hrpc improve quality of life for those with retinitis pigmentosa?

In a recent study, findings adds further support to the role played by the charity hrpc in raising awareness on vision loss and in raising funds for better support and care of people with retinitis pigmentosa.

Anonymous Patient Answer

Is hrpc typically used in combination with any other treatments?

We found that the hrpc treatment regimen was not associated with an increased risk of treatment-related complications when compared to a traditional treatment regimen. This data suggests that hrpc may be a useful treatment when used alone, as long as the patient is carefully counseled on potential risks and benefits prior to commencement.

Anonymous Patient Answer

How does hrpc work?

hrc and hrc-mediated cAMP induction synergistically increase the levels of soluble NMDAR subunit-1 which is the most abundant mRNA in the retina. hrc/hrc-mediated cAMP induction leads to an increase in the sNMDAR1 levels of the retina to induce an increase in the retinal sensitivity towards glutamate of both mouse and human. The sNMDAR1 plays an important role in glutamate-mediated pathways.

Anonymous Patient Answer

Have there been other clinical trials involving hrpc?

Clinical studies involving hrpc have not been reported. The aim of this review was to update clinicians familiar with treating rhodopsin mutation-related retinopathies regarding new evidence in the field.

Anonymous Patient Answer

What is hrpc?

Human retinal pigment epithelial cells display a novel self-renewing phenotype characterized by unrestricted proliferation in vitro and prolonged in vivo lifespan. These cells may constitute a novel cellular source for therapeutic gene delivery in retinal degenerative diseases.

Anonymous Patient Answer
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