Treatment of dry, age-related macular degeneration by epidermal growth factor

ISRCTN ISRCTN12733334
DOI https://doi.org/10.1186/ISRCTN12733334
Submission date
19/04/2020
Registration date
29/05/2020
Last edited
12/12/2023
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Jost Jonas
Scientific

Adenauerplatz 2
Heidelberg
69115
Germany

ORCiD logoORCID ID 0000-0003-2972-5227
Phone +49 6221 3929320
Email Jost.Jonas@medma.uni-heidelberg.de

Study information

Study designClinical interventional prospective randomized double-masked study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEpidermal growth factor for treatment of non-exudative age-related macular degeneration
Study acronymURPES-1
Study objectivesThis study aims to assess the applicability, safety and efficacy of the intravitreal application of EGF (EberprotR) in patients with geographic atrophy.
Ethics approval(s)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
Health condition(s) or problem(s) studiedNon-exudative age-related macular degeneration
InterventionParticipants 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Eberprot (recombinant epidermal growth factor [EGF])
Primary outcome measureSize 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 measuresAt 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 study start date01/11/2019
Completion date31/12/2023
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit50 Years
SexBoth
Target number of participants60
Total final enrolment7
Key inclusion criteria1. 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
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/04/2020
Date of final enrolment30/06/2023

Locations

Countries of recruitment

  • Russian Federation

Study participating centre

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

Sponsor information

Ufa Eye Research Institute
Hospital/treatment centre

90 Pushkin Street
Bashkortostan
Ufa
450077
Russian Federation

Phone +7(347)272-37-75
Email Bikbov.m@gmail.com
Website http://www.ufaeyeinstitute.ru/eng/
ROR logo "ROR" https://ror.org/04grwn689

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/04/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe 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).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 14/07/2021 16/07/2021 Yes No

Editorial Notes

12/12/2023: The study was stopped due to insufficient recruitment.
16/07/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
19/04/2021: The intention to publish date was changed from 01/04/2021 to 01/04/2024.
09/06/2020: Internal review.
27/04/2020: Trial’s existence confirmed by Ufa Eye Research Institute.