- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04856397
Ozurdex in Suboptimal Diabetic Macular Edema Patients (DME)
Ozurdex in Suboptimal Diabetic Macular Edema
연구 개요
상세 설명
Diabetic macular edema (DME) is the most common cause of vision loss in young patients with diabetes. Its pathophysiology starts with decreased retinal oxygen tension that manifests as retinal capillary hyperpermeability and increased intravascular pressure mediated by vascular endothelial growth factor (VEGF) upregulation and retinal vascular autoregulation, respectively. Spectral domain optical coherence tomography (SD-OCT) is the cornerstone of clinical assessment of DME. The foundation of treatment is metabolic control of hyperglycemia and blood pressure. Specific ophthalmic treatments of DME include intravitreal anti-VEGF drug injections, in the form of intravitreal Bevacizumab (Avastin), Ranibizumab (Lucentis), and Aflibercept (Eylea). Intravitreal corticosteroid injections, focal laser photocoagulation, and vitrectomy are other treatment options. A substantial fraction of eyes respond incompletely to all of these modalities resulting in visual loss and disordered retinal structure and vasculature visible on SD-OCT and OCT angiography. There is currently no consensus on when to switch from one treatment to another in the context of a suboptimal response. Our hypothesis is that patients who are switched early to Ozurdex and achieve an OCT proven dry state, achieve better functional outcomes than those patients who are switched late or not at all, by limiting exposure of the retina to potentially damaging inflammatory markers, and the merits associated with less frequent injections.
Suboptimal DME is defined as a central subfoveal retinal thickness of > 300 and the presence of intra or sub-retinal fluid with a minimum BCVA of 20/25 or worse after 3 injections of intravitreal aflibercept, from here on referred to as Eylea. Furthermore, there is some evidence that a subset of patients with refractory DME respond well to intravitreal corticosteroids, specifically, Ozurdex, which is a biodegradable, sustained-release intravitreal dexamethasone implant, designed to be potentially injected between 2-6 months. This medication is currently not covered by the Ontario health benefits plan for patients with DME and comes at a significant cost to patients.
Moreover, recent studies have confirmed the important role of inflammatory ocular cytokines in patients' response to intravitreal treatments in DME, much the same as neovascular age-related macular degeneration. However, it is not known which ocular cytokines determine the degree of response to various treatment modalities for DME.
Here, investigators aim to study the anatomic and visual outcomes, as well as the cytokine profile of patients with suboptimal DME in response to early vs. late switch to intravitreal Ozurdex treatment.
연구 유형
등록 (예상)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Treatment-native patients with DME secondary to type I or type II diabetes mellitus
- Patients who require intravitreal anti-VEGF treatment
- Able to understand English and complete a pain assessment
- Suboptimal DME responders in patients who have received 3 or 6 eylea injections (non-cytokine group)
Exclusion Criteria:
- Deafness or communication disorder, known Dementia, Severe COPD/Asthma (severe lung disorder), Severe OSA, Psychiatric or Anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery; all patients who may need translation, are illiterate, or unable to provide consent.
- Pre-existing ocular pathology confounding outcome (i.e. uveitis, retinal vascular disease, macular degeneration etc.)
- Pre-existing uncontrolled glaucoma/high IOP
- Patients under 18
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: Control group
Responders will be in this category.
These patients will be maintained on intravitreal anti-VEGF therapy for 1 year, with a monthly PRN ("as needed") treatment regimen post 5 monthly loading doses.
|
anti-VEGF medication
|
실험적: Early switch
Suboptimal responders who are switched to intravitreal Ozurdex (monitored monthly and treated PRN at a potential 2-6 month interval) injections after the first 3 monthly loading intravitreal eylea.
|
anti-VEGF medication
Dexamethasone intravitreal implant
다른 이름들:
|
실험적: Late switch
Suboptimal responders who are switched to intravitreal Ozurdex (monitored monthly and treated PRN at a potential 2-6 month interval) injections after the first 6 monthly loading intravitreal eylea
|
anti-VEGF medication
Dexamethasone intravitreal implant
다른 이름들:
|
다른: Non-switch
Suboptimal responders who continue to receive monthly intravitreal anti-VEGF injections.
|
anti-VEGF medication
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Visual acuity
기간: 1 year
|
best corrected visual acuity (BCVA)
|
1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
OCT findings
기간: 1 year
|
Track anatomic outcomes on optical coherence tomography (OCT)
|
1 year
|
OCTa findings
기간: 1 year
|
Track anatomic outcomes on optical coherence tomography angiography (OCTA)
|
1 year
|
Cytokine expression TNFa
기간: 1 year
|
baseline cytokine profile of the aqueous humour of all patients prior to first dose of anti-VEGF.
Cytokine TNFa
|
1 year
|
Cytokine expression IL-8
기간: 1 year
|
baseline cytokine profile of the aqueous humour of all patients prior to first dose of anti-VEGF.
Cytokine IL-8
|
1 year
|
Cytokine expression IL-6
기간: 1 year
|
baseline cytokine profile of the aqueous humour of all patients prior to first dose of anti-VEGF.
Cytokine IL-6
|
1 year
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
Eylea에 대한 임상 시험
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