Effects of Subtenon-injected Autologous Platelet-rich Plasma on Visual Functions in Eyes With Retinitis Pigmentosa

NCT04238858 | Completed DMC

• 1 other identifier: 12-596-16
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose One of the main reasons for apoptosis and dormant cell phases in degenerative retinal diseases such as retinitis pigmentosa (RP) is growth factor withdrawal in the cellular microenvironment. Growth factors and neurotrophins can significantly slow down retinal degeneration and cell death in animal models. One possible source of autologous growth factors is platelet-richplasma.The purpose of this study was to determine if subtenon injections of autologous platelet-rich plasma (aPRP) can have beneficial effects on visual function in RP patients by reactivating dormant photoreceptors.

Conditions

Retinitis Pigmentosa

Keywords

Retinitis pigmentosa; Growth factors; Platelet rich plasma; Visual functions

Outcome Measures

Primary Outcomes (1)

• Visual field sensitivity

  A Humphrey or Octopus 900 visual field analyzer, threshold 30-2 modality, was used at time points of 0,1,2,and 3.In addition, it was used three times before application during experimentation to exclude the learning effect. The MD values, which were obtained from the baseline test and the final examination, were analyzed and compared statistically to make conclusions regarding effectiveness. Visual field analysis could be properly performed on patients whose BCVA values were better than 50 letters in ETDRS chart testing (0.1 decimal)

  Change from baseline visual field sensitivity at 1 month

Study Arms (3)

Before application

ACTIVE COMPARATOR

Forty-nine eyes belonging to 37 patients before injection aPRP.

Biological: Platelet rich plasma

After application

NO INTERVENTION

Forty-nine eyes belonging to 37 patients after injection aPRP.

Sham application

SHAM COMPARATOR

11 patients before - after aPPP injection

Biological: Platelet rich plasma

Interventions

Platelet rich plasma BIOLOGICAL

blood is drawn from the patient's antecubital vein and inserted into four 3.0 ml vacutainer tubes that contain trisodium citrate. These four tubes were placed in a centrifuge machine, and centrifugation was carried out at 2500 rpm (580×g) for 8 min within a 30-min blood collection period. As a result of centrifugation, the plasma was separated in the vacutainer tubes from the remaining blood components. Three different layers formed in the tubes: red blood cells at the bottom, aPRP in the middle layer, and aPPP in the top layer. A total of 1.5 ml of the middle layer (which mainly contained platelets) was withdrawn by syringe, and it was immediately injected into the subtenon space of each eye.

Before application; Sham application

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age or older;
• Diagnosis of any phenotypic variation of RP, confirmed by clinical history, fundus appearance, VF, and electroretinogram;
• Experience of various degrees of VF loss;
• BCVA from light perception of up to 110 letters (equal to 1.6 decimal values) in early treatment of diabetic retinopathy study (ETDRS) chart testing (Topcon CC-100 XP, Japan); \& Mean deviation (MD) values from-33.0 to-5.0 dB with Humphrey or Octopus 900 visual field analysis (threshold 30-2, Sita Standard, Stimulus 3-white);
• Intraocular pressure (IOP) \<22 mmHg.

You may not qualify if:

• The presence of cataracts or other media opacity that might affect the VF, MP, or mfERG recordings;
• The presence of glaucoma, which causes visual field and optic disc changes;
• The presence of any systemic disorder(e.g.,diabetes,neurological disease, or uncontrolled systemic hypertension) that may affect visual functions;
• The habit of smoking.

Sponsors & Collaborators

• Ankara Universitesi Teknokent: lead

Study Sites (1)

Ankara University Biotechnology Institute

Ankara, Türkiye, 06312, Turkey (Türkiye)

Location

Related Publications (4)

• Koenekoop RK. Why some photoreceptors die, while others remain dormant: lessons from RPE65 and LRAT associated retinal dystrophies. Ophthalmic Genet. 2011 Jun;32(2):126-8. doi: 10.3109/13816810.2010.544361. Epub 2011 Jan 26.

  PMID: 21268677 BACKGROUND

• Daftarian N, Kiani S, Zahabi A. Regenerative therapy for retinal disorders. J Ophthalmic Vis Res. 2010 Oct;5(4):250-64.

  PMID: 22737370 BACKGROUND

• Anitua E, Muruzabal F, Tayebba A, Riestra A, Perez VL, Merayo-Lloves J, Orive G. Autologous serum and plasma rich in growth factors in ophthalmology: preclinical and clinical studies. Acta Ophthalmol. 2015 Dec;93(8):e605-14. doi: 10.1111/aos.12710. Epub 2015 Apr 2.

  PMID: 25832910 BACKGROUND

• 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: 29546474 RESULT

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, MD

Model Details: Prospective open-label, before-after-control group comparisions

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 23, 2020
• Study Start: September 1, 2016
• Primary Completion: February 28, 2017
• Study Completion: January 30, 2018
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)