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
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