Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery

May 8, 2019 updated by: Ophthalmica Eye Institute

Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery: A Pilot Study

To-date there have been only very few studies to examine the effect of cataract surgery to patients with wet age-related macular degeneration. The evidence on the effects of cataract surgery in such patients suggests improvement of their visual function and quality of life, but at the same time a subclinical susceptibility to macular edema and exacerbation of the choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To-date there have been only very few studies to examine the effect of cataract surgery to patients with neovascular age-related macular degeneration (AMD), especially in the era of anti-vascular endothelial growth factor (anti-VEGF) therapy. Furthermore the issue of optimum treatment regimen that should be used in the peroperative period has never been addressed. Since the human life expectancy gradually increases, the number of patients who are under anti-VEGF intravitreal injections for wet AMD will be increasing accordingly. Cataract surgery in such patients, despite guarded prognosis has been proved to improve their visual function and quality of life. On the other hand, it has been shown that cataract surgery induces anatomic changes based on optical coherence tomography analysis, suggesting a subclinical susceptibility to postoperative cystoid macular edema or exacerbation of choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Kalamaria
      • Thessaloníki, Kalamaria, Greece, 54655
        • Recruiting
        • Ophthalmica Eye Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Active choroidal neovascularization (at least 1 intravitreal injection in the past 12 months) associated with AMD and involving the foveal center
  • BCVA of 1.0 (LogMAR) or better
  • Duration of wet AMD less than 3 years

Exclusion Criteria:

  • Coexisting ocular pathology potentially affecting visual acuity and/or status of the macula including diabetic retinopathy, advanced glaucoma, retinal vein occlusion, retinal detachment
  • Newly diagnosed patients with wet AMD who are on anti-VEGF treatment for less than 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intensive Treatment
The participants will receive x1 intraoperative and 3 postop monthly injections. Subsequently, they will follow the treat and extend protocol.
Drug: Ranibizumab
Intravitreal Ranibizumab is approved for the treatment of wet AMD. In this study we will compare an intensive injection protocol versus the standard treat and extend protocol in wet AMD patients undergoing cataract surgery.
Other Names:
  • Lucentis
ACTIVE_COMPARATOR: Standard Treatment
The participants will continue their preoperative treat and extend protocol .
Drug: Ranibizumab
Intravitreal Ranibizumab is approved for the treatment of wet AMD. In this study we will compare an intensive injection protocol versus the standard treat and extend protocol in wet AMD patients undergoing cataract surgery.
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity change from baseline
Time Frame: 12 months
Difference in visual acuity change from baseline at the end of the follow-up period.
12 months
Difference in the number of injections
Time Frame: 12 months
Difference in the number of injections at the end of the follow-up period.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Status of the macular degeneration based on optical coherence tomography parameter, as compared to baseline
Time Frame: 12 months
The status of the age-related macular degeneration will be evaluated based on optical coherence tomography parameters at the at final follow-up and compared to the baseline. Our main focus is to identify any subfoveal scarring and/ or subfoveal atrophy that may develop during the follow-up and assess changes from the baseline state of the macula.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ophthalmica Eye Institute

Investigators

  • Principal Investigator: Paris G Tranos, PhD, Head of Uveitis & Retinal Surgery Department, Ophthalmica Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

April 23, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (ACTUAL)

May 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/001_OPH-ECSAMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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