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

Primary Purpose

Wet Macular Degeneration, Cataract Extraction

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
Ophthalmica Eye Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Macular Degeneration

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ophthalmica Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intensive Treatment

Standard Treatment

Arm Description

The participants will receive x1 intraoperative and 3 postop monthly injections. Subsequently, they will follow the treat and extend protocol.

The participants will continue their preoperative treat and extend protocol .

Outcomes

Primary Outcome Measures

Visual acuity change from baseline
Difference in visual acuity change from baseline at the end of the follow-up period.
Difference in the number of injections
Difference in the number of injections at the end of the follow-up period.

Secondary Outcome Measures

Status of the macular degeneration based on optical coherence tomography parameter, as compared to baseline
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.

Full Information

First Posted
April 23, 2019
Last Updated
May 8, 2019
Sponsor
Ophthalmica Eye Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03944070
Brief Title
Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery
Official Title
Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophthalmica Eye Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Macular Degeneration, Cataract Extraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive Treatment
Arm Type
Active Comparator
Arm Description
The participants will receive x1 intraoperative and 3 postop monthly injections. Subsequently, they will follow the treat and extend protocol.
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
The participants will continue their preoperative treat and extend protocol .
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual acuity change from baseline
Description
Difference in visual acuity change from baseline at the end of the follow-up period.
Time Frame
12 months
Title
Difference in the number of injections
Description
Difference in the number of injections at the end of the follow-up period.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Status of the macular degeneration based on optical coherence tomography parameter, as compared to baseline
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paris G Tranos, PhD
Phone
00302310263063
Ext
103
Email
tranos@ophthalmica.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paris G Tranos, PhD
Organizational Affiliation
Head of Uveitis & Retinal Surgery Department, Ophthalmica Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmica Eye Institute
City
Thessaloníki
State/Province
Kalamaria
ZIP/Postal Code
54655
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Periklis Markousis, MSc
Phone
2310263063
Ext
102
Email
markousis@ophthalmica.gr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25601333
Citation
Kessel L, Erngaard D, Flesner P, Andresen J, Tendal B, Hjortdal J. Cataract surgery and age-related macular degeneration. An evidence-based update. Acta Ophthalmol. 2015 Nov;93(7):593-600. doi: 10.1111/aos.12665. Epub 2015 Jan 20.
Results Reference
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PubMed Identifier
26095263
Citation
Saraf SS, Ryu CL, Ober MD. The effects of cataract surgery on patients with wet macular degeneration. Am J Ophthalmol. 2015 Sep;160(3):487-492.e1. doi: 10.1016/j.ajo.2015.06.006. Epub 2015 Jun 19.
Results Reference
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Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery

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