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出境医 / 临床实验 / Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery

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

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
Wet Macular Degeneration Cataract Extraction Drug: Ranibizumab Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 1, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 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 Name: 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 Name: Lucentis
Outcome Measures
Primary Outcome Measures :
  1. Visual acuity change from baseline [ Time Frame: 12 months ]
    Difference in visual acuity change from baseline at the end of the follow-up period.

  2. Difference in the number of injections [ Time Frame: 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 [ 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Paris G Tranos, PhD 00302310263063 ext 103 tranos@ophthalmica.gr

Locations
Layout table for location information
Greece
Ophthalmica Eye Institute Recruiting
Thessaloníki, Kalamaria, Greece, 54655
Contact: Periklis Markousis, MSc    2310263063 ext 102    markousis@ophthalmica.gr   
Sponsors and Collaborators
Ophthalmica Eye Institute
Investigators
Layout table for investigator information
Principal Investigator: Paris G Tranos, PhD Head of Uveitis & Retinal Surgery Department, Ophthalmica Eye Institute
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE May 9, 2019
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Visual acuity change from baseline [ Time Frame: 12 months ]
    Difference in visual acuity change from baseline at the end of the follow-up period.
  • Difference in the number of injections [ Time Frame: 12 months ]
    Difference in the number of injections at the end of the follow-up period.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery
Official Title  ICMJE Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery: A Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Wet Macular Degeneration
  • Cataract Extraction
Intervention  ICMJE 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 Name: Lucentis
Study Arms  ICMJE
  • Active Comparator: Intensive Treatment
    The participants will receive x1 intraoperative and 3 postop monthly injections. Subsequently, they will follow the treat and extend protocol.
    Intervention: Drug: Ranibizumab
  • Active Comparator: Standard Treatment
    The participants will continue their preoperative treat and extend protocol .
    Intervention: Drug: Ranibizumab
Publications *
  • 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. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03944070
Other Study ID Numbers  ICMJE 2017/001_OPH-ECSAMD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ophthalmica Eye Institute
Study Sponsor  ICMJE Ophthalmica Eye Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paris G Tranos, PhD Head of Uveitis & Retinal Surgery Department, Ophthalmica Eye Institute
PRS Account Ophthalmica Eye Institute
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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