Effectiveness of Biosimilar Ranibizumab in the Management of Diabetic Macular Edema (ERBDME)
2026년 6월 17일 업데이트: Ehab Mohamed Elsayed Mohamed Saad, Benha University
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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
60
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Benha
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Banhā, Benha, 이집트, 13111
- Benha University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
Inclusion Criteria:
• 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
Exclusion Criteria:
• 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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in best-corrected visual acuity (BCVA)
기간: Baseline to final follow-up (minimum 3-6 months)
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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.
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Baseline to final follow-up (minimum 3-6 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in central macular thickness (CMT)
기간: Baseline to final follow-up (minimum 3-6 months)
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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.
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Baseline to final follow-up (minimum 3-6 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 1월 1일
기본 완료 (실제)
2026년 4월 1일
연구 완료 (실제)
2026년 4월 15일
연구 등록 날짜
최초 제출
2026년 6월 17일
QC 기준을 충족하는 최초 제출
2026년 6월 17일
처음 게시됨 (실제)
2026년 6월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 17일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- DME-RANIBIZUMAB-BIOSIMILAR-202
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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