MedDataX Logo

The Ranibizumab Plus Transpupillary Thermotherapy for Neovascular Age-Related Macular Degeneration (AMD) Study

NCT ID: NCT00599222

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Neovascular age-related macular degeneration (AMD) is the leading cause of severe vision loss in the Western world. Intravitreal ranibizumab has recently become the treatment of choice for neovascular (AMD). Limitations to ranibizumab however include the high cost for the drug and the need for frequent intravitreal re-injections. The investigators' hypothesis is that when ranibizumab is combined with transpupillary thermotherapy (TTT) the number of necessary retreatments with Lucentis will be significantly reduced as compared to ranibizumab alone.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. For this reason, anti-VEGF drugs, in particular ranibizumab, as become the treatment of choice for neovascular AMD. Ranibizumab use is limited by its high cost. Also, ranibizumab requires repeated (sometimes up to monthly) intravitreal injections for many years. Strategies to reduce the burden of this treatment on the patient as well as on the health care system will be critical. Combination therapy is an attractive such possibility. Transpupillary thermotherapy (TTT) is a technique by which vascular occlusion can be induced by delivering radiation at near infrared intensity to the target tissue through the pupil. Several reports have indicated that TTT may be used to slow disease progression in patients with neovascular AMD. In this study we examine whether combined ranibizumab and TTT will reduce the number of ranibizumab injections compared with ranibizumab alone (sham TTT). The study will go on for 2 years with an interim report after 1 year.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neovascular Age-related Macular Degeneration

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

AMD macular degeneration anti-VEGF laser treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TTT

TTT is given every three months

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type BIOLOGICAL

0.5 mg intravitreal injection

TTT

Intervention Type PROCEDURE

Transpupillary thermotherapy (TTT)

Sham TTT

Sham TTT is given every three months

Group Type SHAM_COMPARATOR

ranibizumab

Intervention Type BIOLOGICAL

0.5 mg intravitreal injection

Sham TTT

Intervention Type PROCEDURE

Sham Transpupillary thermotherapy (TTT)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ranibizumab

0.5 mg intravitreal injection

Intervention Type BIOLOGICAL

TTT

Transpupillary thermotherapy (TTT)

Intervention Type PROCEDURE

Sham TTT

Sham Transpupillary thermotherapy (TTT)

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lucentis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with subfoveal neovascular AMD with either classic/predominantly classic or occult lesions
* visual acuity =\> 20/200

Exclusion Criteria

* subretinal fibrosis or atrophy under the fovea
* patients previously treated for neovascular AMD in the study eye
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Anders Kvanta

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anders Kvanta

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anders Kvanta

Role: PRINCIPAL_INVESTIGATOR

St Eriks Eye Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St Eriks Eye Hospital

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Soderberg AC, Algvere PV, Hengstler JC, Soderberg P, Seregard S, Kvanta A. Combination therapy with low-dose transpupillary thermotherapy and intravitreal ranibizumab for neovascular age-related macular degeneration: a 24-month prospective randomised clinical study. Br J Ophthalmol. 2012 May;96(5):714-8. doi: 10.1136/bjophthalmol-2011-300721. Epub 2012 Jan 12.

Reference Type DERIVED
PMID: 22241923 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.sankterik.se

Hospital homepage

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LUTA001

Identifier Type: -

Identifier Source: org_study_id