Study of Port Delivery System with ranibizumab given every 36 weeks in patients with neovascular age-related macular degeneration

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What is this study about?

This study focuses on patients with neovascular Age-Related Macular Degeneration, also known as wet AMD, which is an eye condition causing vision loss due to abnormal blood vessel growth in the retina. The study tests a device called the Port Delivery System that contains the medicine ranibizumab. This system is designed to deliver medication directly into the eye through a small, implantable device, rather than through traditional eye injections.

The purpose of this research is to evaluate how well the Port Delivery System works when the medicine is refilled every 36 weeks. The medication being studied, ranibizumab, is already approved for treating wet AMD when given as regular eye injections. In this study, participants will receive the implanted delivery system and will have it refilled with medication according to a set schedule over approximately 72 weeks.

During the study, patients will have regular eye examinations and vision tests to monitor their condition. The Port Delivery System will be surgically implanted into the eye at the beginning of the study, and then the medicine will be refilled through this system. The study will compare this new delivery method to traditional eye injections and will monitor both the effectiveness of the treatment and any side effects that may occur.

1 Initial screening

Your eligibility will be evaluated if you are 50 years or older and have been diagnosed with neovascular age-related macular degeneration (nAMD) within the past 24 months

Your vision will be tested using a special chart to confirm you can see at least 34 letters at 4 meters distance

Your previous eye treatment records and images will be reviewed

2 Treatment initiation

A small medical device called Port Delivery System (PDS) will be surgically implanted in your eye

The device contains ranibizumab, a medication that helps treat your eye condition

You will need to stay under observation for up to 37 days after the surgery to monitor your recovery

3 Regular monitoring and refills

The device will be refilled with medication every 36 weeks

Regular eye examinations will be performed to check your vision and eye health

Your vision will be measured using the same chart as during screening

Pictures of your eye will be taken to monitor the thickness of specific areas of your retina

4 Additional treatments

If needed, you may receive additional eye injections of ranibizumab between the scheduled refills

The need for extra treatment will be determined based on your eye examination results

5 Study completion

The study will continue for 72 weeks (approximately 1.5 years)

Final vision assessments will be performed at weeks 68 and 72

You will be asked about your treatment preference through a questionnaire at weeks 24 and 72

Who Can Join the Study?

  • Must be 50 years of age or older when signing the consent form
  • Must have been diagnosed with neovascular age-related macular degeneration (nAMD) within the past 24 months before screening visit
  • Must have shown positive response to previous anti-VEGF eye injections (treatments that help prevent abnormal blood vessel growth in the eye)
  • Must have stable eye disease as shown on OCT scan (a detailed image of the retina) at enrollment, confirmed by specialists
  • Must have good enough vision to read at least 34 letters on a standard eye chart from 4 meters away (approximately equal to 20/200 vision)
  • Must have previous OCT scan images from when the condition was first diagnosed and before starting any treatment

Who Cannot Join the Study?

  • Previous eye surgery within 3 months before starting the study
  • Active eye infection or inflammation
  • History of retinal detachment (separation of the light-sensitive layer of the eye from its supporting tissue)
  • Uncontrolled glaucoma (increased pressure inside the eye)
  • Previous treatment with other medications for wet AMD in the study eye within the last 4 months
  • Known allergies to the study medication or its components
  • History of other serious eye conditions that could interfere with the study results
  • Pregnancy or breastfeeding
  • Current participation in another clinical trial
  • Serious medical conditions that could affect study participation
  • Unable to follow study instructions or attend scheduled visits
  • History of stroke or heart attack within the past 3 months
  • Active bleeding disorders or use of blood-thinning medications

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Medizinische Hochschule Hannover Hanover Germany
Mw-Med Sp. z o.o. Cracow Poland
NOE Landesgesundheitsagentur Mistelbach Austria
Universitaetsmedizin Goettingen Goettingen Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Rostock University Medical Center Rostock Germany

Other Sites

Site Name City Country Status
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha Prague Czechia
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Edouard Herriot Lyon France
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
University General Hospital Of Heraklion Heraklion Greece
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o. Olsztyn Poland
General University Hospital Of Larissa Larissa Greece
Virgen del Rocío University Hospital Sevilla Spain
Quinze-Vingts National Ophthalmology Hospital Paris France
Klinikum Chemnitz gGmbH Chemnitz Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola Rome Italy
Rigshospitalet Copenhagen Denmark
Universita’ Degli Studi Di Ferrara Ferrara Italy
Clinique Du Pont De Chaume Montauban France
University Hospital Ostrava Ostrava Czechia
Oftalmika Sp. z o.o. Bydgoszcz Poland
Omuydnts nqzbhenpt Mphhu Bcndagik abdr nzgnajmkt Sepuasirpkvxl kjgax Mlada Boleslav Czechia
Olrfrott Sxeuqqs Ktcgkbdh w Kckkphpkcd Sahaa Katowice Poland
Pfzugws Shu z olof Gliwice Poland
Oobnzymklca Sxp z ocuh Bydgoszcz Poland
Soltdwi Sgxnslwq Ltjwdnr Skpx Bielsko-Biala Poland
Kobhmzw Ottsvijxtscj Jayws Brnweh Sdd z oawu Lodz Poland
Iolbkrgn Ouiqvbynifwqwau Dy lualfszqbqiyr Johhr Vljap Nantes France
Lakie Gzxfupb Hbfuxbhh Og Aljdfo Athens Greece
Gotlsyr Ozpqenbgerll pimpq Eghybd Wntplvga Katowice Poland
Uwwjnxeepczqjjxfasldq Dfawjskorqg Ahy Duesseldorf Germany
Alxmsb Uoroczwyyx Hjrfkavy Aarhus Denmark
Aeedkvq Okydkwdbwqc Urcjosuwustwc Cdfufurmbpfu Dwtfr Sthepy E Dzant Silfwne Da Tiwiug Turin Italy
Umqbrgfwxkokqbkwnqpuh Wjpfbpyrk Aoe Wuerzburg Germany
Fhjcbkksr Phaj Lo Iehxiurwlwome Bauqruljz Dxt Hwnakyzx Uwpyqubckgjoh Ld Poy Madrid Spain
Jbmgzlrd Kcqzux Uiasgllkbp Linz Austria
Uzzjnxdcvs Gdcukis Hwhnndbw Aeczhwi Athens Greece
Helpnqem Ulebropfrqxrws Svupylvfxy &iqvdwr Hxplfuu dw Hyqfytcpcmg STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.09.2025
Czechia Czechia
Recruiting
01.09.2025
Denmark Denmark
Recruiting
01.09.2025
France France
Recruiting
01.09.2025
Germany Germany
Recruiting
01.09.2025
Greece Greece
Recruiting
01.09.2025
Italy Italy
Recruiting
01.09.2025
Poland Poland
Recruiting
01.09.2025
Spain Spain
Recruiting
01.09.2025

Trial locations

Investigated drugs:

Port Delivery System with ranibizumab (PDS)
This is a specialized implant system that delivers ranibizumab medication directly to the eye. It is designed to treat neovascular age-related macular degeneration, which is a condition that affects vision in older adults. The system works by continuously releasing the medication over time, reducing the need for frequent eye injections. The delivery system is implanted into the eye during a surgical procedure and can be refilled with medication when needed.

Ranibizumab
This is a medication used to treat eye conditions by blocking the growth of abnormal blood vessels in the back of the eye. It helps prevent vision loss and may improve vision in people with age-related macular degeneration. The medication works by targeting and inhibiting a protein that promotes the growth of new blood vessels that can damage vision.

Neovascular Age-Related Macular Degeneration (nAMD) – A progressive eye condition that develops when abnormal blood vessels grow underneath the macula in the retina. These abnormal vessels can leak fluid and blood into the retina, causing distortion of central vision. The condition typically affects people over the age of 50, gradually causing blurred or distorted central vision while peripheral vision usually remains intact. The disease affects the ability to see fine details, read, recognize faces, and perform other activities requiring detailed vision. It represents the advanced form of age-related macular degeneration, developing more rapidly than the dry form of the disease.

Trial ID:
2024-516924-32-00
Protocol code:
MR45625
Trial Phase:
Therapeutic confirmatory (Phase III)

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