Comparison of Ranibizumab Monotherapy and Ranibizumab Combination Therapies in Recurrent or Persistent Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Comparison of Intravitreal Dexamethasone With Intravitreal Ranibizumab Versus Intravitreal Ranibizumab Monotherapy in Recurrent or Persistent Choroidal Neovascularization Secondary to Age-related Macular Degeneration A Prospective, Randomized, Clinical Study
Age-related macular degeneration (AMD) is by far the most common disorder in the group of irreversible causes of visual disability. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease process and severely compromises the highly developed functions of the macula, such as perception of details, central fixation, color vision, and reading ability. AMD-related visual impairment is associated with a loss of autonomy and quality of life. Current therapeutic approaches target vascular endothelial growth factor (VEGF), which has been identified as a main cytokine in the pathogenesis of nAMD. Ranibizumab, the fab-fragment of an antibody targeting VEGF is approved for the treatment of nAMD applied intravitreally in monthly intervals until the disease activity is stopped. However, a significant proportion of patients with nAMD suffer from persistent or recurring disease with the need of continuous anti-VEGF therapy over months and years, often leading to irreversible changes in the photoreceptor layer and the pigment epithelium.
Recent studies regarding the treatment of nAMD utilized different forms of therapies, combining photodynamic therapy with verteporfin (PDT) and ranibizumab, as well as therapeutic regimen containing steroids. Even though these studies did not provide evidence that combination therapies are superior to ranibizumab monotherapy, studies were only conducted with patients with previously untreated nAMD. Therefore, currently there is no alternative therapeutic approach for patients with recurrent or persistent form of nAMD after multiple treatments with ranibizumab monotherapy.
The purpose of this study is to assess the treatment effect of reduced fluence PDT and intravitreal ranibizumab versus intravitreal dexamethasone and ranibizumab versus intravitreal ranibizumab monotherapy in patients with persistent or recurrent choroidal neovascularization (CNV) due to AMD.
The investigators hypothesis is that these findings will offer new insights in the management of persistent or recurrent CNV secondary to AMD.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Vienna, 오스트리아, 1090
- Department of Ophthalmology, Medical University of Vienna
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients 50 years of age or older.
- Patients with persistent or recurrence subfoveal CNV lesion secondary to AMD
- Patients who have a BCVA score better than 20/400 in the study eye using ETDRS.
- At least 6 initial intravitreal ranibizumab monotherapy
- The initial intravitreal ranibizumab treatment performed within the last 6 - 12 months.
Exclusion Criteria:
- Any prior initial intravitreal treatment other than intravitreal ranibizumab.
- History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Visit 1, or a history of post-operative complications within the last 12 months preceding Visit 1 in the study eye (uveitis, cyclitis etc.).
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation).
- Aphakia or absence of the posterior capsule in the study eye.
- Presence of a retinal pigment epithelial tear involving the macula in the study eye.
- Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the three-month study period to prevent or treat visual loss that might result from that condition.
- Active intraocular inflammation (grade trace or above) in the study eye.
- Any active infection involving eyeball adnexa.
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
- Other ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for three or more consecutive days at any time within six months prior to screening or during the course of the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intravitreal dexamethasone and intravitreal ranibizumab
Patients will receive intravitreal dexamethasone using a special drug delivery system and same day intravitreal ranibizumab. Study medications are initially given at the baseline visit. At each subsequent monthly follow-up visit, ranibizumab is administered if further visual deterioration or persistence of sub-/intraretinal fluid is detected in the examination. At month 3, 6, 9 and 12 further treatments with intravitreal dexamethasone in combination with intravitreal ranibizumab are given if leakage is detected in fluorescein or indocyanine green (FLA or ICG) angiography, in case of further vision decrease or persistence of sub-/intraretinal fluid in OCT. |
Patients will receive intravitreal dexamethasone using a special drug delivery system and same day intravitreal ranibizumab. Study medications are initially given at the baseline visit. At each subsequent monthly follow-up visit, ranibizumab is administered if further visual decrease or persistence of sub-/intraretinal fluid is detected in the examination. At month 3, 6, 9 and 12 further treatments with intravitreal dexamethasone in combination with intravitreal ranibizumab are given if leakage is detected in fluorescein or indocyanine green (FLA or ICG) angiography, in case of further vision decrease or persistence of sub-/intraretinal fluid in OCT. |
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활성 비교기: Intravitreal ranibizumab
Patients will receive intravitreal ranibizumab monotherapy (cohort 3).
Study medications are initially given at the baseline visit.
At each subsequent monthly follow-up visit, ranibizumab is administered if further visual deterioration or persistence of sub-/intraretinal fluid is detected in the examination
|
Patients will receive intravitreal ranibizumab monotherapy (cohort 3).
Study medications are initially given at the baseline visit.
At each subsequent monthly follow-up visit, ranibizumab is administered if further visual deterioration or persistence of sub-/intraretinal fluid is detected in the examination
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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• Central visual function.
기간: 12 months
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12 months
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• Changes of intraretinal morphologies (central retinal thickness).
기간: 12 months
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12 months
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2차 결과 측정
결과 측정 |
기간 |
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• Measurement of levels of proteins in the ocular fluid.
기간: 12 months
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12 months
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• Perfusion of the neovascular net (FLA and ICG).
기간: 12 months
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12 months
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• Chorioretinal perfusion (ICG).
기간: 12 months
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12 months
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• Retinal sensitivity (mfERG, Nidek MP-1 microperimetry)
기간: 12 months
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Stefan Sacu, MD, Department of Ophthalmology, Medical University of Vienna
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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