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

Sponsor
Ophthalmica Eye Institute
Study ID
NCT03944070
Status
Unknown

Conditions

  • Cataract Extraction
  • Wet Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
May 9, 2019
Start date
Jan 1, 2018
Status verified
May 2019
Primary completion
Jan 31, 2020
Completion
Jan 31, 2020

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intensive Treatment
    The participants will receive x1 intraoperative and 3 postop monthly injections. Subsequently, they will follow the treat and extend protocol.
  • Active Comparator: Standard Treatment
    The participants will continue their preoperative treat and extend protocol .

Primary Outcome Measure

Visual acuity change from baseline [ Time Frame: 12 months ]

Central Contacts

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