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

Sponsor
Ophthalmica Eye Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT03944070
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery: A Pilot Study
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Jan 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity change from baseline [12 months]

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

    2. Difference in the number of injections [12 months]

      Difference in the number of injections at the end of the follow-up period.

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ophthalmica Eye Institute Thessaloníki Kalamaria Greece 54655

    Sponsors and Collaborators

    • Ophthalmica Eye Institute

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ophthalmica Eye Institute
    ClinicalTrials.gov Identifier:
    NCT03944070
    Other Study ID Numbers:
    • 2017/001_OPH-ECSAMD
    First Posted:
    May 9, 2019
    Last Update Posted:
    May 9, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Degeneration
    Cataract
    Wet Macular Degeneration
    Ranibizumab

    Study Results

    No Results Posted as of May 9, 2019