Anti-VEGF TreatmentERBDMENCT07663370
Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema
An observational study of Anti-VEGF Treatment and Ranibizumab, run by Benha University at 1 site in Egypt.
Trial summary
Diabetic macular edema (DME) is a leading cause of vision loss in patients with diabetes. Anti-VEGF agents are widely used to improve vision and reduce retinal swelling. However, treatment cost remains a major barrier in many healthcare systems. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Anti-VEGF Treatment, Ranibizumab, Biosimilar
- What is being tested?
- Ranibizumab biosimilar
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 15 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients with type 1 or type 2 diabetes mellitus diagnosed with center-involving diabetic macular edema confirmed by optical coherence tomography (OCT), who received at least one intravitreal injection of ranibizumab biosimilar at the Retina Unit, Department of Ophthalmology, Benha University Hospitals, between January 2022 and April 2026. Eligible eyes had a minimum follow-up duration of 3-6 months with available baseline and follow-up data for best-corrected visual acuity (BCVA) and central macular thickness (CMT). Patients with other causes of macular edema, prior recent anti-VEGF therapy within the washout period, significant media opacity affecting imaging, coexisting retinal pathology affecting vision, prior vitreoretinal surgery, or incomplete records were excluded. The population reflects a real-world retrospective cohort treated in routine clinical practice.
Who may be able to join
- • Age ≥18 years
- Diagnosis of type 1 or type 2 diabetes mellitus
- Center-involving diabetic macular edema confirmed by OCT
- Received at least one intravitreal ranibizumab biosimilar injection
- Minimum follow-up duration of 3-6 months
Who cannot join
- • Macular edema due to causes other than diabetes
- Prior anti-VEGF treatment within specified washout period
- Significant media opacity affecting imaging
- Coexisting retinal pathology affecting vision (e.g., AMD, RVO)
- Prior vitreoretinal surgery
- Incomplete records or inadequate follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema: A Retrospective Observational Cohort Study
Diabetic macular edema (DME) is a leading cause of vision loss in patients with diabetes. Anti-VEGF agents are widely used to improve vision and reduce retinal swelling. However, treatment cost remains a major barrier in many healthcare systems.
This study evaluates the real-world effectiveness and safety of a ranibizumab biosimilar in patients with DME. Medical records of adult patients treated at a tertiary ophthalmology center will be reviewed. Changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) will be analyzed from baseline to final follow-up, along with treatment burden and safety outcomes.
The findings aim to provide evidence on visual and anatomical outcomes following biosimilar anti-VEGF therapy in routine clinical practice.
Read the detailed description
This study is a retrospective observational cohort designed to evaluate the real-world effectiveness and safety of intravitreal ranibizumab biosimilar in patients with diabetic macular edema (DME). Medical records of adult patients diagnosed with type 1 or type 2 diabetes mellitus who received at least one injection of ranibizumab biosimilar at the Retina Unit, Department of Ophthalmology, Benha University Hospitals, between January 2022 and April 2026 will be reviewed. Eligible cases will include eyes with center-involving DME confirmed by optical coherence tomography (OCT) and a minimum follow-up period of 3-6 months. Baseline demographic, systemic, and ocular characteristics, including age, sex, diabetes duration, HbA1c level, lens status, prior ocular treatment, best-corrected visual acuity (BCVA), and central macular thickness (CMT), will be collected. Follow-up data will include changes in BCVA and CMT, number of injections received, and treatment regimen (loading dose, pro re nata, or treat-and-extend protocols). Outcomes will assess mean changes in BCVA and CMT from baseline to final follow-up, as well as the proportion of eyes achieving clinically meaningful visual and anatomical improvement. Safety outcomes will include ocular adverse events such as endophthalmitis, intraocular inflammation, retinal detachment, and intraocular pressure elevation, as well as systemic thromboembolic events. Statistical analysis will be performed using SPSS software, with appropriate parametric or non-parametric tests applied based on data distribution, and a p-value <0.05 considered statistically significant. The study will be conducted following Institutional Review Board approval and in accordance with the Declaration of Helsinki, with all data anonymized to ensure patient confidentiality.
- Conditions
- Anti-VEGF Treatment, Ranibizumab, Biosimilar
- Being tested
- Ranibizumab biosimilar
- Keywords
- Diabetic macular edema, ranibizumab biosimilar, anti-VEGF therapy, optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab biosimilarDrug
Intravitreal ranibizumab biosimilar administered as part of routine clinical care for the treatment of center-involving diabetic macular edema. Patients included in this retrospective cohort received at least one intravitreal injection of the biosimilar during the study period. Treatment regimens were determined by the treating physician and may have included an initial loading phase followed by pro re nata (PRN) or treat-and-extend (T\&E) protocols based on disease activity assessed by clinical examination and optical coherence tomography (OCT). The intervention was not assigned by the investigators, and no randomization or experimental treatment allocation was performed.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab biosimilar treatment group | This cohort includes adult patients with type 1 or type 2 diabetes mellitus diagnosed with center-involving diabetic macular edema confirmed by optical coherence tomography (OCT), who received at least one intravitreal injection of ranibizumab biosimilar during the study period. All data are obtained retrospectively from medical records at the Retina Unit, Department of Ophthalmology, Benha University Hospitals. Patients were managed according to routine clinical practice using ranibizumab biosimilar administered via intravitreal injection, with treatment regimens including loading doses, pro re nata (PRN), or treat-and-extend (T\&E) protocols as determined by the treating physician. No control or comparator group is included in this observational study. Outcomes of interest include changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), injection burden, and the incidence of ocular and systemic adverse events during follow-up. Receives: Drug: Ranibizumab biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best-corrected visual acuity (BCVA)
Mean change in best-corrected visual acuity (BCVA) from baseline to the final follow-up visit after intravitreal ranibizumab biosimilar treatment in patients with diabetic macular edema. BCVA will be recorded in Snellen or converted to ETDRS equivalent letters where applicable, and compared between baseline and post-treatment measurements.
Measured: Baseline to final follow-up (minimum 3-6 months)
Secondary outcomes (1)
Change in central macular thickness (CMT)
Mean change in central macular thickness (CMT) measured by optical coherence tomography (OCT) from baseline to final follow-up after intravitreal ranibizumab biosimilar treatment in eyes with diabetic macular edema.
Measured: Baseline to final follow-up (minimum 3-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jan 2022
- Primary completion1 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-VEGF TreatmentStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663370
- Sponsor's protocol ID
- DME-RANIBIZUMAB-BIOSIMILAR-202
- Acronym
- ERBDME
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema: A Retrospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07663370
- Acronym / sponsor ID
- ERBDME / DME-RANIBIZUMAB-BIOSIMILAR-202
- Conditions
- Anti-VEGF Treatment, Ranibizumab, Biosimilar
- Keywords
- Diabetic macular edema, ranibizumab biosimilar, anti-VEGF therapy, optical coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic macular edema (DME) is a leading cause of vision loss in patients with diabetes. Anti-VEGF agents are widely used to improve vision and reduce retinal swelling. However, treatment cost remains a major barrier in many healthcare systems.
This study evaluates the real-world effectiveness and safety of a ranibizumab biosimilar in patients with DME. Medical records of adult patients treated at a tertiary ophthalmology center will be reviewed. Changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) will be analyzed from baseline to final follow-up, along with treatment burden and safety outcomes.
The findings aim to provide evidence on visual and anatomical outcomes following biosimilar anti-VEGF therapy in routine clinical practice.
Detailed description
This study is a retrospective observational cohort designed to evaluate the real-world effectiveness and safety of intravitreal ranibizumab biosimilar in patients with diabetic macular edema (DME). Medical records of adult patients diagnosed with type 1 or type 2 diabetes mellitus who received at least one injection of ranibizumab biosimilar at the Retina Unit, Department of Ophthalmology, Benha University Hospitals, between January 2022 and April 2026 will be reviewed. Eligible cases will include eyes with center-involving DME confirmed by optical coherence tomography (OCT) and a minimum follow-up period of 3-6 months. Baseline demographic, systemic, and ocular characteristics, including age, sex, diabetes duration, HbA1c level, lens status, prior ocular treatment, best-corrected visual acuity (BCVA), and central macular thickness (CMT), will be collected. Follow-up data will include changes in BCVA and CMT, number of injections received, and treatment regimen (loading dose, pro re nata, or treat-and-extend protocols). Outcomes will assess mean changes in BCVA and CMT from baseline to final follow-up, as well as the proportion of eyes achieving clinically meaningful visual and anatomical improvement. Safety outcomes will include ocular adverse events such as endophthalmitis, intraocular inflammation, retinal detachment, and intraocular pressure elevation, as well as systemic thromboembolic events. Statistical analysis will be performed using SPSS software, with appropriate parametric or non-parametric tests applied based on data distribution, and a p-value <0.05 considered statistically significant. The study will be conducted following Institutional Review Board approval and in accordance with the Declaration of Helsinki, with all data anonymized to ensure patient confidentiality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab biosimilar treatment group | – | Drug: Ranibizumab biosimilarThis cohort includes adult patients with type 1 or type 2 diabetes mellitus diagnosed with center-involving diabetic macular edema confirmed by optical coherence tomography (OCT), who received at least one intravitreal injection of ranibizumab biosimilar during the study period. All data are obtained retrospectively from medical records at the Retina Unit, Department of Ophthalmology, Benha University Hospitals. Patients were managed according to routine clinical practice using ranibizumab biosimilar administered via intravitreal injection, with treatment regimens including loading doses, pro re nata (PRN), or treat-and-extend (T\&E) protocols as determined by the treating physician. No control or comparator group is included in this observational study. Outcomes of interest include changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), injection burden, and the incidence of ocular and systemic adverse events during follow-up. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with type 1 or type 2 diabetes mellitus diagnosed with center-involving diabetic macular edema confirmed by optical coherence tomography (OCT), who received at least one intravitreal injection of ranibizumab biosimilar at the Retina Unit, Department of Ophthalmology, Benha University Hospitals, between January 2022 and April 2026. Eligible eyes had a minimum follow-up duration of 3-6 months with available baseline and follow-up data for best-corrected visual acuity (BCVA) and central macular thickness (CMT). Patients with other causes of macular edema, prior recent anti-VEGF therapy within the washout period, significant media opacity affecting imaging, coexisting retinal pathology affecting vision, prior vitreoretinal surgery, or incomplete records were excluded. The population reflects a real-world retrospective cohort treated in routine clinical practice.
Key inclusion criteria (5 listed)
- • Age ≥18 years
Key exclusion criteria (6 listed)
- • Macular edema due to causes other than diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ranibizumab biosimilarIntravitreal ranibizumab biosimilar administered as part of routine clinical care for the treatment of center-involving diabetic macular edema. Patients included in this retrospective cohort received at least one intravitreal injection of the biosimilar during the study period. Treatment regimens were determined by the treating physician and may have included an initial loading phase followed by pro re nata (PRN) or treat-and-extend (T\&E) protocols based on disease activity assessed by clinical examination and optical coherence tomography (OCT). The intervention was not assigned by the investigators, and no randomization or experimental treatment allocation was performed. | Drug | Ranibizumab biosimilar treatment group |
Primary outcome
Change in best-corrected visual acuity (BCVA)
Time frame: Baseline to final follow-up (minimum 3-6 months)
Mean change in best-corrected visual acuity (BCVA) from baseline to the final follow-up visit after intravitreal ranibizumab biosimilar treatment in patients with diabetic macular edema. BCVA will be recorded in Snellen or converted to ETDRS equivalent letters where applicable, and compared between baseline and post-treatment measurements.
1 secondary outcome
Change in central macular thickness (CMT)
Time frame: Baseline to final follow-up (minimum 3-6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-VEGF Treatment and Ranibizumab, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in best-corrected visual acuity (BCVA) (time frame: Baseline to final follow-up (minimum 3-6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.