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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03944070

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted May 9, 2019

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:Wet Macular Degeneration
    Cataract Extraction
  • Intervention/Treatment: Drug: Ranibizumab
  • 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
  • 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 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.
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.
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
  • Ages Eligible for Study: 50 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

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

Locations

Greece, Kalamaria
Ophthalmica Eye Institute
Thessaloníki

Sponsors and Collaborators

Ophthalmica Eye Institute

Investigators

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

More Information