NCT04252534

Brief Summary

The aim of this study is to investigate whether natural progression rate can be slowed down with subtenon PRP or PRP application combined with rEMS in retinitis pigmentosa cases.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

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

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

January 31, 2020

Last Update Submit

February 1, 2020

Conditions

Retinitis Pigmentosa

Keywords

Retinitis pigmentosaElectromagnetic stimulationPlatelet rich plasmaMagnovisionEllipsoid zone

Outcome Measures

Primary Outcomes (1)

  • Ellipsoid zone width (EZW)

    The ellipsoid zone (EZ) is an image of the inner and outer segments of photoreceptor cells on OCT view

    Change from baseline EZW at 12 months

Study Arms (3)

Repetitive electromagnetic stimulation

ACTIVE COMPARATOR

Group 1 consists of 20 RP patients (40 eyes) who received combined rEMS with PRP. In this group, patients received rEMS for 30 minutes before subtenon PRP injections. In this group, 3 loading doses were applied at 3-week intervals. Then 2 booster dose were applied at 6-month intervals.

Combination Product: PRP combined MagnovisionBiological: PRP

Platelet rich plasma

ACTIVE COMPARATOR

Group 2 consists of 20 RP patients (40 eyes). In this group, patients received only subtenon PRP injections. In this group, 3 loading doses were applied at 3-week intervals. Then 2 booster dose were applied at 6-month intervals.

Biological: PRP

Natural course

NO INTERVENTION

Group 3 consists of 20 RP patients (40 eyes). Patients in this group did not accept any interventional application and were only followed up. The

Interventions

PRP combined MagnovisionCOMBINATION_PRODUCT

The rEMS helmet is used to stimulate the retina and visual pathways. (MagnovisionTM) combined with subtenon platelet rich plasma injection

Repetitive electromagnetic stimulation
PRPBIOLOGICAL

Fresh autologous platelet rich plasma, injected subtenon space.

Platelet rich plasmaRepetitive electromagnetic stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • RP patients in any phenotype with vision over 50 letters

You may not qualify if:

  • Media opacity and nystagmus presence to prevent EZW imaging in OCT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Arslan U, Ozmert E, Demirel S, Ornek F, Sermet F. Effects of subtenon-injected autologous platelet-rich plasma on visual functions in eyes with retinitis pigmentosa: preliminary clinical results. Graefes Arch Clin Exp Ophthalmol. 2018 May;256(5):893-908. doi: 10.1007/s00417-018-3953-5. Epub 2018 Mar 15.

    PMID: 29546474BACKGROUND

  • Ozmert E, Arslan U. Management of Deep Retinal Capillary Ischemia by Electromagnetic Stimulation and Platelet-Rich Plasma: Preliminary Clinical Results. Adv Ther. 2019 Sep;36(9):2273-2286. doi: 10.1007/s12325-019-01040-2. Epub 2019 Aug 5.

    PMID: 31385285BACKGROUND

  • Ozmert E, Arslan U. Management of retinitis pigmentosa by Wharton's jelly derived mesenchymal stem cells: preliminary clinical results. Stem Cell Res Ther. 2020 Jan 13;11(1):25. doi: 10.1186/s13287-020-1549-6.

    PMID: 31931872BACKGROUND

  • Arslan U, Ozmert E. Management of Retinitis Pigmentosa via Platelet-Rich Plasma or Combination with Electromagnetic Stimulation: Retrospective Analysis of 1-Year Results. Adv Ther. 2020 May;37(5):2390-2412. doi: 10.1007/s12325-020-01308-y. Epub 2020 Apr 18.

    PMID: 32303913DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Umut Arslan, MD

    Ankara Universitesi Teknokent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparative, open label
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator, MD

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

January 1, 2017

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share