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.
調査の概要
状態
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Vienna、オーストリア、1090
- Department of Ophthalmology, Medical University of Vienna
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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• Central visual function.
時間枠：12 months
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12 months
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• Changes of intraretinal morphologies (central retinal thickness).
時間枠：12 months
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12 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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• Measurement of levels of proteins in the ocular fluid.
時間枠：12 months
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12 months
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• Perfusion of the neovascular net (FLA and ICG).
時間枠：12 months
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12 months
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• Chorioretinal perfusion (ICG).
時間枠：12 months
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12 months
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• Retinal sensitivity (mfERG, Nidek MP-1 microperimetry)
時間枠：12 months
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12 months
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協力者と研究者
捜査官
- 主任研究者：Stefan Sacu, MD、Department of Ophthalmology, Medical University of Vienna
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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