Study on the Effectiveness and Safety of Ranibizumab for Patients with Wet Age-Related Macular Degeneration Using a 36-Week Refill System

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What is this study about?

This clinical trial is focused on studying a condition called neovascular age-related macular degeneration (nAMD), which is a type of eye disease that can lead to vision loss. The study is testing a treatment called ranibizumab, which is delivered through a special device known as the Port Delivery System. This system allows the medication to be released slowly over time. The purpose of the study is to evaluate how effective and safe this treatment is when refilled every 36 weeks compared to every 24 weeks.

Participants in the study will receive the treatment through an implantation procedure. The study will last for a period of time, during which participants will have regular check-ups to monitor their vision and overall health. The study will compare the changes in vision between the two refill schedules to determine which is more beneficial for patients with nAMD.

Throughout the study, participants will be monitored for any side effects or changes in their condition. The study aims to provide valuable information on the best way to manage nAMD using the Port Delivery System with ranibizumab, potentially offering a new option for those affected by this eye disease.

1 initial visit and screening

The initial visit involves a comprehensive eye examination to confirm the diagnosis of neovascular age-related macular degeneration (nAMD).

Eligibility is assessed based on previous treatments and visual acuity data. The eye must have been treated with at least three anti-VEGF injections in the past six months.

2 baseline assessment

A baseline assessment is conducted to measure the best-corrected visual acuity (BCVA) using the ETDRS chart.

Additional imaging tests such as fundus photography and OCT are performed to evaluate the condition of the eye.

3 implantation procedure

The Port Delivery System (PDS) with ranibizumab is implanted in the eye. This device allows for continuous delivery of the medication.

The procedure is performed under local anesthesia and involves a small incision in the eye.

4 follow-up visits

Regular follow-up visits are scheduled to monitor the eye’s response to treatment and the condition of the implant.

Visual acuity is assessed, and any adverse effects are recorded.

5 refill-exchange procedure

The PDS is refilled with ranibizumab 100 mg/mL every 36 weeks or 24 weeks, depending on the assigned group.

This procedure is similar to the initial implantation and is performed in a clinical setting.

6 final assessment

At the end of the study period, a final assessment is conducted to evaluate changes in visual acuity and overall eye health.

Patient satisfaction with the treatment is also measured using questionnaires.

Who Can Join the Study?

The patient must have been diagnosed with neovascular age-related macular degeneration (nAMD) within the last 9 months before the screening visit. Neovascular age-related macular degeneration is an eye condition that can cause vision loss.
The patient should have received at least three treatments with anti-VEGF injections for nAMD in the eye within the last 6 months before the screening visit. Anti-VEGF injections are treatments that help reduce vision loss in certain eye conditions.
The patient must have past records of their vision before starting anti-VEGF treatment for nAMD and up to the time they join the study.
The patient should have a best-corrected visual acuity (BCVA) of 34 letters or better. Best-corrected visual acuity is a measure of the best vision a person can achieve with glasses or contact lenses, tested using a special chart.
The patient can have any type of nAMD lesions, but these lesions must affect the macula, which is the central part of the retina responsible for sharp vision.
The patient must have clear enough eye structures and adequate pupil dilation to allow for detailed eye imaging tests. These tests include fundus photography, fluorescein angiography, fundus autofluorescence imaging, and OCT images, which help doctors see inside the eye.
Both male and female patients are eligible to participate in the study.
The study includes patients who may be considered part of a vulnerable population.

Who Cannot Join the Study?

Patients who have any other eye diseases that could affect vision.
Patients who have had eye surgery within the last three months.
Patients who have an eye infection or inflammation.
Patients who are allergic to the study medication or any of its ingredients.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who have a serious medical condition that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Medical University Of Graz	Graz	Austria
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
Centro Medico Teknon-Grupo Quironsalud	Barcelona	Spain
Hekfisip Urxbdqqedecm Gzbzitg Do Cwkvxfcry	Sant Cugat Del Valles	Spain
Htmehjtf Vfoj dqlatbwy	Barcelona	Spain
Uzjfcpggek Hnvrzhxs Cmscvcm	Cologne	Germany
Umurpnxysevkuzulgloig Tmtblfqly Auq	Tuebingen	Germany
Fwfecdyply Ioupo Cc Gbxzci Oqgecyvc Maqfhihu Pmsrfoxvmqy	Milan	Italy
Hbqfobku Ccnjfb Di Byvqluzrv	Barcelona	Spain
Uusuvbwpjapqgtcnk Pmgikxduapl Dmmgt Moydqg	Ancona	Italy
Hzfwisxn Cubydww Ssc Cdmvob	Madrid	Spain
Uwowbfbokcilbchdoelwq Mdfvohdw Awo	Munster	Germany
Uapwkweyrliyrcvhppwdb Hrlbwbylot Afk	Heidelberg	Germany
Mczigoi Cuqerl &kahhaf Uqhrkhmadm Oi Fiztdezl	Freiburg Im Breisgau	Germany
Ucizmypqyb Mceshar Cdopqu Hpsiazvibygarzykw	Hamburg	Germany
Isgiiaol famm Kodhzhroq Ttbbpurdwuxukvgrmld ule Ilkmbcvtmeua Uvc gzpir	Ulm	Germany
Ufqrwvtdaqjf Zzwawmzlbv Gjqi	Gent	Belgium
Ayozevp Sqaahpaag Ulhkzhlwuhykh Favrux Coskttje	Udine	Italy
Hmmetwxm Uxiczkvwhaqwi Pexqoq Dq Hkjqsa Dw Mlllfchrpuy	Majadahonda	Spain
Hbixiqnl Uesrcviursnpf Rpk Hacodlt	Valladolid	Spain
Ffpdczqfk A Df Rmyespzpjb	Paris	France
Aotjmne Sgpjadwpl Ubflyujaefnfm Gjjxhdmo Isojqirz	Trieste	Italy
Ckvwprnc Shyetigm Iigeybxj	L'hospitalet De Llobregat	Spain
Kagxznzhj Trnkeqjrnvptguvkdzq Crurslf mmm	Cottbus	Germany
Cjt Cdzkw Rxnmtlncjss	Lyon	France
Akeyixmwieeb Prwfs Dcz Koci Gmvb	Frankfurt	Germany
Iyiyt Oanfzctz Sroab Cptzn Dcj Cwkfqara	Negrar di Valpolicella	Italy
Uxydnrgllrcqzeezqahrc Rjegxqssvv Amf	Regensburg	Germany
Cjffpx Hljttnqnjpr Uhresfgshwskm Dv Dxzzm	Dijon	France
Ljafao Mtxqsaeixf Uvrehifjlp On Mzqvxg	Munich	Germany
Afsmjpn Shgabifns Lsuebc 2 Lollabpf Vyjxo Cjiatl	Chieti	Italy
Azzh Fhwmmmfkzdhxigga Swqto	Milan	Italy
Kwzzhmrz dgt Stbrd Llqlwdihblln ap Rzdpj gbihv	Ludwigshafen Am Rhein	Germany
Hspwfgwn Swjjc Mbqqq Dvyuz Mkryenirmzav	Perugia	Italy
Ibnjpwwfm Ofeosaulzkeug Ftoakdmusgrffi Slrm	Oviedo	Spain
Ujbxcednae Cznhnrqpx Hhwpfxre Qjxcu Fmakfjc	Brussels	Belgium
Clsodf Dy Omaxveyytcyk Bgdmqkhpn Smgp	Barcelona	Spain
Cibcdzf Df Ooiydtshmlmj Dy Clcfcfm Sevh	Cordoba	Spain
Kkzgoolqveb Kosjeoxy Srop Gtdc	Sulzbach	Germany
Alzmwapizcra Ae Sc Ffzkgjuutkpjnstkpsr Mxvzdres	Munster	Germany
Oyrwcmpxlmvm Vxwfqfrqzylq Sajg	Burjassot	Spain
Cpsavqe Bmhwouj Smmo	Madrid	Spain
Cwautl Msfsiqdtyc Pextfjr D Ogptmqziahkej	Marseille	France
Frucexzjnx Gaxhjxzgmb Pov Lw Sssqyk E Li Rjpgpog Ip Ofynqfzmfcpw	Rome	Italy
Skdbrv Razsqr Tgqhzc	Bordeaux	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	21.03.2022
Belgium	Not recruiting	21.03.2022
France	Not recruiting	21.03.2022
Germany	Not recruiting	21.03.2022
Italy	Not recruiting	21.03.2022
Spain	Not recruiting	21.03.2022

Trial locations

Investigated Drugs:

Ranibizumab

Ranibizumab is a medication used in this clinical trial to treat patients with neovascular age-related macular degeneration, a condition that affects vision. In this study, ranibizumab is delivered through a special device called the port delivery system. This system allows the medication to be released slowly over time, reducing the need for frequent injections. The trial is investigating how effective and safe it is to refill this system every 36 weeks compared to every 24 weeks, by measuring changes in the patients’ vision.

Investigated Diseases:

Age-related macular degeneration

Neovascular age-related macular degeneration (nAMD) – This is a chronic eye condition that affects the macula, the central part of the retina responsible for sharp vision. It occurs when abnormal blood vessels grow under the retina and macula, leading to leakage of blood and fluid. This leakage can cause the macula to lift from its normal position, resulting in rapid and severe vision loss. The disease typically progresses with symptoms such as blurred or distorted vision, and dark spots in the central vision. Over time, if untreated, it can lead to significant vision impairment. The progression of nAMD can vary, with some individuals experiencing a slow decline in vision, while others may notice a rapid deterioration.

Trial ID:

2023-507130-24-00

Protocol code:

WR42221

Trial Phase:

Therapeutic confirmatory (Phase III)

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