Panitumumab to prevent the progression of eyeball elongation in adults with nearsightedness and macular degeneration
| ISRCTN | ISRCTN96896687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96896687 |
- Submission date
- 24/10/2022
- Registration date
- 03/03/2023
- Last edited
- 12/12/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
In experimental studies, antibodies injected into the back of the eye (intravitreal injections) against epidermal growth factor (EGF), EGF family members (amphiregulin, neuregulin-1, betacellulin, epigen, and epiregulin) and the EGF receptor (EGFR) were associated with a reduction in lens-induced axial elongation and in physiological eye elongation in guinea pigs and in non-human primates. Here we examined the intraocular tolerability and safety of a fully human monoclonal IgG2-antibody against EGFR, already in oncology in clinical use, as potential future therapy against axial elongation in adult eyes with pathological myopia. This study will evaluate the safety and tolerability of single and multiple intravitreal injections of panitumumab in adult highly myopic patients with myopic macular degeneration and characterize the pharmacokinetic and immunogenic potential.
Who can participate?
Patients aged 50 years old and under with nearsightedness and macular degeneration
What does the study involve?
Patients will receive intravitreal injections (into the back of the eye) of panitumumab (doses: 0.6 mg, 1.2 mg, or 1.6 mg) in intervals ranging between 1 month and several months. Patients will undergo repeated clinical and ophthalmological examinations.
What are the possible benefits and risks of participating?
The benefits of participating are the potential reduction in further axial elongation and thus a reduction of the risk of progression of myopic maculopathy. The risks are related to the injection, including the risk of infection which occurs after 1 in 3000 injections, and to the potential (yet unlikely) toxicity of panitumumab if applied intraocularly.
Where is the study run from?
Medical Faculty Mannheim of Heidelberg University (Germany)
When is the study starting and how long is it expected to run for?
November 2021 to December 2026
Who is funding the study?
Medical Faculty Mannheim of Heidelberg University (Germany)
Ufa Eye Research Institute (Russia)
Who is the main contact?
Prof Jost Jonas, jost.jonas@medma.uni-heidelberg.de (Germany)
Contact information
Principal Investigator
Medical Faculty Mannheim
Department of Ophthalmology
Kutzerufer 1
Mannheim
68167
Germany
 ORCID ID |
0000-0003-2972-5227 |
|---|---|
| Phone | +4962213929320 |
| jost.jonas@medma.uni-heidelberg.de |
Study information
| Study design | Single-center open-label multiple-dose phase I study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Intravitreal panitumumab for prevention of myopic axial elongation in highly myopic adult eyes with myopic macular degeneration |
| Study objectives | In experimental studies, intravitreally applied antibodies against epidermal growth factor (EGF), EGF family members (amphiregulin, neuregulin-1, betacellulin, epigen, epiregulin) and against the EGF receptor (EGFR) were associated with a reduction in lens-induced axial elongation and in physiological eye elongation in guinea pigs and in non-human primates. The hypothesis is that the EGFR antibody panitumumab, already in oncology in clinical use, may be a potential therapy against axial elongation in adult eyes with pathologic myopia, if applied intravitreally. |
| Ethics approval(s) | Approved 28/09/2021, the Ethics Committee of the Academic Council of the Ufa Eye Research Institute (Ufa Eye Research Institute, 90 Pushkin Street, Ufa 450077, Russia; +7 (347) 272 37 75; ufaeyenauka@mail.ru), ref: none available |
| Health condition(s) or problem(s) studied | Adult highly myopic patients with myopic macular degeneration |
| Intervention | Any patient attending the Ufa Eye Research Institute and Hospital and fulfilling the inclusion criteria could be included in the study. The intervention will consist of intraocular injection of panitumumab (doses: 0.6 mg, 1.2 mg, or 1.6 mg) in intervals ranging between 1 month and several months. Re-injections will be performed every two months, under the condition (criteria) that the previous injections were well tolerated without observed intraocular or systemic side effects. Patients will be re-examined on the day of every injection and re-injection and at day 1 and day 7 after each injection. Follow-up is 6 months for each arm. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Panitumumab |
| Primary outcome measure | Intraocular safety, defined by signs of intraocular inflammation, such as cells in the aqueous humour, increased Tyndall phenomenon, cells in the vitreous body, intraocular pressure, measured by slit lamp biomicroscopy of the anterior and posterior segment of the eye and applanation tonometry, at baseline and at every re-examination, i.e., at day 1 and 7 and at one and two months after each injection to search for signs of acute inflammation |
| Secondary outcome measures | Axial length, measured by laser interferometric biometry at baseline, at every re-injection, and at the study end at 6 months |
| Overall study start date | 01/11/2021 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Aged <50 years old 2. Axial length >26.0 mm 3. Myopic macular degeneration of stage 4 (foveal patchy atrophy) 4. Best corrected visual acuity >1.0 logMAR (logarithm of the minimal angle of resolution) (20/200 Snellen equivalent) |
| Key exclusion criteria | Not meeting the inclusion criteria |
| Date of first enrolment | 05/11/2021 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Ufa
450077
Russian Federation
Sponsor information
University/education
C/o Prof. Mukharram Bikbov
90 Pushkin Street
Ufa
450077
Russian Federation
| Phone | +7(347)272-37-75 |
|---|---|
| bikbov.m@gmail.com | |
"ROR" |
https://ror.org/04grwn689 |
Funders
Funder type
University/education
No information available
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- University Medical Centre Mannheim, Mannheim Üniversitesi Hastanesi, Университетская клиника Мангейм, Universitätsklinikum Mannheim, UMM
- Location
- Germany
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| 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 and peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available from the principal investigator upon reasonable request, Prof. Jost B. Jonas, Jost.Jonas@medma.uni-heidelberg.de. All measured and assessed data will be shared, in an anonymized format and will be available starting from the study end. Consent was required and obtained from participants and data anonymization was carried out in a standard manner. |
Editorial Notes
12/12/2023: The following changes were made:
1. The recruitment end date was changed from 31/12/2023 to 31/12/2025.
2. The overall study end date was changed from 31/12/2024 to 31/12/2026.
3. The intention to publish date was changed from 31/12/2023 to 31/12/2025.
22/12/2022: Trial's existence confirmed by the Ethics Committee of the Academic Council of the Ufa Eye Research Institute.
