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
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
Scientific
Adenauerplatz 2
Heidelberg
69115
Germany
 ORCID ID |
0000-0003-2972-5227 |
|---|---|
| Phone | +49 6221 3929320 |
| Jost.Jonas@medma.uni-heidelberg.de |
Study information
| Study design | Clinical interventional prospective randomized double-masked study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Epidermal growth factor for treatment of non-exudative age-related macular degeneration |
| Study acronym | URPES-1 |
| Study objectives | This 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/11/2019 |
| Completion date | 31/12/2023 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 7 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/04/2020 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Ufa, Bashkortostan
450077
Russian Federation
Sponsor information
Hospital/treatment centre
90 Pushkin Street
Bashkortostan
Ufa
450077
Russian Federation
| Phone | +7(347)272-37-75 |
|---|---|
| Bikbov.m@gmail.com | |
| Website | http://www.ufaeyeinstitute.ru/eng/ |
"ROR" |
https://ror.org/04grwn689 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | 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). |
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.
