Condition category
Eye Diseases
Date applied
19/04/2020
Date assigned
29/05/2020
Last edited
09/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Age-related macular degeneration (AMD) is a common condition that affects the middle part of your vision. It usually first affects people in their 50s and 60s. It doesn't cause total blindness. But it can make everyday activities like reading and recognising faces difficult.
Pseudophakia follows eye surgery when an artificial lens replaces a person's natural lens.
The aim of the study is to investigate the effect of injecting a hormone into the eye to aid recovery after lens replacement.

Who can participate?
Patients aged 50+ years with pseudophakia, presence of geographic atrophy, normal intraocular pressure, lack of any other ocular disease except for age-related macular degeneration, and absence of any malignancy.

What does the study involve?
Participants will be randomly allocated to receive monthly injections of EGF (EberprotR) (experimental group) or pseudo-injection (control group) into the eye. The pseudo-injection includes the same preparations as for the true injection, with the only difference that an invasive procedure, i.e., the injection is not carried out. For three days after the injection and pseudo-injection, the eyes will receive eye drops 5x/day.
At baseline, at one month, three months and six months after baseline, the eyes will undergo an ophthalmological examination including refractometry, biometry, electroretinography, tonometry, and optical coherence tomography.

What are the possible benefits and risks of participating?
The potential benefits of the study and for the individual study participant in the study group are that for the time, a therapy may become available for the dry form of age-related macular degeneration

Where is the study run from?
Ufa Eye Research Institute (Bashkortostan, Russia)

When is the study starting and how long is it expected to run for?
April 2020 to December 2023

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Prof. Jost Jonas
Jost.Jonas@medma.uni-heidelberg.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jost Jonas

ORCID ID

http://orcid.org/0000-0003-2972-5227

Contact details

Adenauerplatz 2
Heidelberg
69115
Germany
+49 6221 3929320
Jost.Jonas@medma.uni-heidelberg.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Epidermal growth factor for treatment of non-exudative age-related macular degeneration

Acronym

URPES-1

Study hypothesis

This study aims to assess the applicability, safety and efficacy of the intravitreal application of EGF (EberprotR) in patients with geographic atrophy.

Ethics approval

Approved 14/11/2019, Ethics Committee of Ufa Eye Research Institute (90 Pushkin Street, Ufa 450008, Bashkortostan, Russia; +7 (347) 273-29-52; Ufnii-ethiccom@yandex.ru), ref: URPES-01

Study design

Clinical interventional prospective randomized double-masked study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Non-exudative age-related macular degeneration

Intervention

Participants will be randomly allocated to study or control groups using a random number selection method.

For each study participant of the study group, the eye with the worse best-corrected visual acuity will repeatedly receive intravitreal injections (50 µL) of EberprotR in a dose of 0.75ug/50µL or higher in intervals of 4 weeks.

For each study participant of the control group, the eye with the worse best-corrected visual acuity will repeatedly receive a pseudo-intravitreal injection in intervals of 4 weeks. The pseudo-injection includes the same preparations as for the true injection, with the only difference that an invasive procedure, i.e., the injection is not carried out.

For three days after the injection and pseudo-injection, the eyes will receive prednisolone acetate 1.0% eye drops in combination with a topical antibiotic (e.g. gentamicin eye drops or in combination) 5x/day.

At baseline, at one month, three months and six months after baseline, the eyes will undergo an ophthalmological examination including refractometry, biometry, electroretinography, tonometry, and optical coherence tomography.

Intervention type

Drug

Phase

Phase II

Drug names

Eberprot (recombinant epidermal growth factor [EGF])

Primary outcome measure

Size of geographic atrophies measured on fundus images obtained by optical coherence tomography at baseline, one month, three months and six months after baseline

Secondary outcome measures

At baseline, one month, three months and six months after baseline:
1. Visual acuity measured using by ophthalmologists or optometrists as best corrected visual acuity under standardized conditions and using modified Early Treatment of Diabetic Retinopathy Study (ETDRS) charts (Light House Low Vision Products, New York, NY) at a distance of 4 meters. If the optotypes cannot be read at a distance of 4m, one will continue with optotypes held at a distance of 1m. If the optotypes cannot be read at that distance the ability of finger counting and the detectability of hand movements at a distance of 1m or 50cm will be tested. If hand movements cannot be seen, the light perception with correct or incorrect projection will be assessed

Overall trial start date

01/11/2019

Overall trial end date

31/12/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age of 50 + years
2. Pseudophakia
3. Presence of geographic atrophy
4. Normal intraocular pressure
5. Lack of any other ocular disease except for age-related macular degeneration, and absence of any malignancy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2020

Recruitment end date

30/06/2023

Locations

Countries of recruitment

Russian Federation

Trial participating centre

Ufa Eye Research Insitute
90 Pushkin Street
Ufa, Bashkortostan
450077
Russian Federation

Sponsor information

Organisation

Ufa Eye Research Institute

Sponsor details

90 Pushkin Street
Bashkortostan
Ufa
450077
Russian Federation
+7(347)272-37-75
Bikbov.m@gmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.ufaeyeinstitute.ru/eng/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Prof. Mukharram Bikbov (Bikbov.m@gmail.com) and / or Prof. Jost B. Jonas (jost.jonas@medma.uni-heidelberg.de). They shall become available from June 2021 onwards. These data can then statistically be re-analyzed in an anonymized form, with consent from the study participants).

Intention to publish date

01/04/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/06/2020: Internal review. 27/04/2020: Trial’s existence confirmed by Ufa Eye Research Institute.