Aflibercept for Macular Oedema With Underlying Retinitis Pigmentosa (AMOUR) Study (AMOUR)
Prospective Non-randomised Exploratory Study to Assess the Safety and Efficacy of Aflibercept (Eylea) in Cystoid Macular Oedema (CMO) Associated With Retinitis Pigmentosa (RP)
調査の概要
詳細な説明
This is a 17 month phase II therapeutic exploratory trial in Cystoid Macular Oedema (CMO) with underlying Retinitis Pigmentosa (RP). The study design is a prospective, open-label, interventional non-randomised trial. All patients enrolled in the study will receive intravitreal injections of Aflibercept (Eylea).
There will be a 9 month recruitment window and patient participation will be for 12 months; 30 patients aged 16 years or older presenting in the Medical Retina and Genetics clinics at Moorfields Eye Hospital with Cystoid Macula Oedema (CMO) with underlying Retinitis Pigmentosa (RP) will be approached by the study team to discuss participation in the AMOUR study and be given a patient information leaflet. If patients decide to participate in the study they will be invited to the NIHR Moorfields Clinical Research Facility for a baseline screening where written informed consent will be given by the patient and various assessments will be performed to confirm eligibility.
Patients enrolled in the study will receive intravitreal injections of 2mg of 40mg/ml of Aflibercept (Eylea) solution in the study eye. In the first three months, patients will receive a loading dose of Aflibercept (Eylea) with one injection every four weeks. After the first three months, treatment frequency will follow a treat and extend protocol for up to 12 months from date of study enrolment. Extension from 4 weekly to 6,8,10 and 12 week follow up will occur when there is no further reduction in macula fluid compared to the previous visit. Patients will receive a minimum of 5 injections before being deemed as non-responders to treatment.
Imaging and assessments such as optical coherence tomography imaging, microperimetry and visual acuity will be used to assess response to treatment.
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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London、イギリス、EC1V 2PD
- Moorfields Eye Hospital
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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:
- CMO in association with RP
- > 16 years of age
- Unilateral or Bilateral CMO (the worse eye only will be treated - defined as the eye with a greater central macular thickness (CMT) on OCT)
- No previous oral treatment for CMO for last 3 months
- No previous peribulbar or intravitreal treatment for CMO in the study eye for last 3 months
- No previous topical treatment for CMO in the study eye for last 1 month
- Central visual impairment that in the view of the Principal Investigator is due to CMO
- BCVA better than 3/60
Exclusion Criteria:
- Insufficient patient cooperation or media clarity to allow adequate fundus imaging.
- Evidence of visually significant vitreo-retinal traction or epiretinal membrane on OCT that in the Principal Investigator's opinion is highly likely to significantly limit the efficacy of intravitreal therapy.
- History of cataract surgery within prior 3 months or cataract surgery anticipated within 6 months of starting the study.
- Any anti-VEGF treatment to study eye within 3 months.
- History of YAG capsulotomy performed within 3 months.
- Uncontrolled Intraocular pressure (IOP) > = 24 mmHg for ocular hypertension (on topical IOP lowering medications)
- Advanced glaucoma (in the opinion of a glaucoma specialist).
- Patients with active or suspected ocular or periocular infections
- Patients with active severe intraocular inflammation.
- Patients with a new, untreated retinal tear or detachment
- Patients with a stage 3 or 4 macular hole
- Thromboembolic event (MI/CVA/Unstable Angina) within 6 months.
- Pregnancy or family planned within 15 months
- Females who are breast feeding
- Known allergy or hypersensitivity to anti-VEGF products
Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 12 weeks after treatment discontinuation. The MHRA advise double contraception.
Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment.
Note: Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：Aflibercept (Eylea)
All patients recruited to the study will receive 3 loading intravitreal injections of Aflibercept (Eylea) at monthly intervals followed by a treat and extend protocol up to 12 months.
Extension from monthly to 6, 8, 10 and 12 week follow-up will occur when there is evidence of OCT stability in the view of the investigator i.e. there is no further reduction in macular fluid compared to the previous visit.
All patients will receive 5 injections before considering them non-responders.
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2mg of 40mg/ml of Eylea Solution administered via intravitreal injection every four weeks for three months (loading dose), followed by a treat and extend protocol up to 12 months. Extension from monthly to 6, 8, 10 and 12 week follow up will occur where there is no reduction in macula oedema compared with the previous visit. Number of cycles; minimum of 5 injections and maximum of 13 injections per study eye.
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The efficacy of Eylea in cystoid macular oedema (CMO) associated with Retinitis Pigmentosa (RP)
時間枠：baseline to 12 months
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Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) at 12 months will assess the efficacy of the study; the number of Participants With Abnormal mean central macular thickness values.
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baseline to 12 months
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The safety of Eylea in cystoid macular oedema (CMO) associated with Retinitis Pigmentosa (RP)
時間枠：baseline to 12 months
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Safety will be assessed by the Adverse Events that are related to treatment and Mean Central Macular Thickness (CMT) on Spectral Domain OCT (SDOCT) to assess if Eylea has reduced fluid accumulation in the retina.
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baseline to 12 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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The mean central macular thickness (CMT) on Spectral Domain OCT (SDOCT) at 6 months
時間枠：Baseline to 6 months
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Baseline to 6 months
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The mean change in Central Macular Thickness on Spectral Domain Optical Coherence tomography (SD-OCT) from baseline to 6 months and baseline to 12 months
時間枠：baseline to 6 months and baseline to 12 months
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baseline to 6 months and baseline to 12 months
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The mean Best Corrected Visual Acuity (BCVA) using the ETDRS visual acuity chart at 6 and 12 months
時間枠：baseline to 6 months and baseline to 12 months
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baseline to 6 months and baseline to 12 months
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The mean change in ETDRS BCVA from baseline to 6 months and baseline to 12 months
時間枠：baseline to 6 months and baseline to 12 months
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baseline to 6 months and baseline to 12 months
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The mean macular volume on SDOCT at 6 and 12 months
時間枠：baseline to 6 months and baseline to 12 months
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baseline to 6 months and baseline to 12 months
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The mean change in macular volume on SDOCT from baseline to 6 months and baseline to 12 months
時間枠：baseline to 6 months and baseline to 12 months
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baseline to 6 months and baseline to 12 months
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Report all Adverse Events and Serious Adverse Events
時間枠：From date of first injection for first patient to the end of the study (17 months)
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From date of first injection for first patient to the end of the study (17 months)
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The mean retinal sensitivity using microperimetry at 6 and 12 months
時間枠：At 6 months and at 12 months
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At 6 months and at 12 months
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The mean change in retinal sensitivity using microperimetry from baseline to 6 months and baseline to 12 months
時間枠：From baseline to 6 months and baseline to 12 months
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From baseline to 6 months and baseline to 12 months
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The mean number of intravitreal injections administered
時間枠：17 months (from first patient first visit to last patient last visit)
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17 months (from first patient first visit to last patient last visit)
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協力者と研究者
協力者
捜査官
- 主任研究者：Michel Michaelides, Professor、Moorfields Eye Hospital, Institute of Ophthalmology
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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 (見積もり)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MICM1014
- 2015-003723-65 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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