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Trial · NCT02850263

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal afliberceptBaseline and 12 months
BCVA (Best Corrected Visual Acuity): process to measure with the help of a retinoscope, auto-refractor or phoropter how much power is needed to bring the eye to normal, perfectly focused vision) when performed in addition to that at baseline and 12 months. ETDRS Chart: charts imprinted with lines of letters decreasing in size from largest on top to smallest on the bottom to determine visual acuity.
PrimaryChange in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal afliberceptBaseline and 12 months
SecondaryChange in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal afliberceptBaseline and 24 months
SecondaryChange in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal afliberceptBaseline and 24 months
SecondaryChange in non-refracted visual acuity in patients with DMO treated with intravitreal afliberceptBaseline, 12 and 24 months
Secondary
Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept differentiated by BCVA baseline characteristics
Baseline, 12 and 24 months
SecondaryChange in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristicsBaseline, 12 and 24 months
SecondaryProportion (%) of patients discontinuing intravitreal aflibercept treatmentBaseline, 12 and 24 months
SecondaryTime between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatmentBaseline
SecondaryThe time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatmentBaseline
SecondaryProportion (%) of treated eyes with 5, 10 and 15 letter gain / lossBaseline, 12 and 24 months
SecondaryProportion (%) of sites that adhere to their stated treatment protocol12 and 24 months
SecondaryChange in QoL score measured by NEI VFQ-25Baseline, 12 and 24 months
SecondaryChange in macular volumeBaseline, 12 and 24 months
SecondaryChange in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) lettersBaseline, 12 and 24 months
SecondaryChange in non-refracted visual acuity (VA).for the fellow eyeBaseline, 12 and 24 months
SecondaryNumber of DMO treatments required for the fellow eyeBaseline, 12 and 24 months
SecondaryNumber of visits performed (resources) to assess the fellow eyeBaseline, 12 and 24 months
SecondaryNumber of clinical procedures performed (resources) to assess the fellow eyeBaseline, 12 and 24 months
SecondaryNumber of adverse events as a measure of safety and tolerability24 months

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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