Long-term follow-up and cross-over of treatment with high-density micropulse laser and half-dose photodynamic therapy in participants of the PLACE trial for chronic central serous chorioretinopathy.

Long-term follow-up and cross-over of treatment with high-density micropulse laser and half-dose photodynamic therapy in participants of the PLACE trial for chronic central serous chorioretinopathy. - CROSS-OVER/LONG-TERM FOLLOW-UP STUDY for chronic CSC, following PLACE trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40728

Enrollment

100

Registered

2015-03-31

Start date

2015-04-22

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic central serous chorioretinopathy

Interventions

Patients who will be included in the cross-over study, will receive an intervention. If a patient received half-dose photodynamic therapy during the PLACE trial, high-density subthreshold micropulse

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Only participants of the PLACE trial can be enrolled for this study. In the Cross-over study, the following patients will be included: - Subjects with persistent SRF on OCT at the final follow-up visit of the PLACE trial (7-8 months after Treatment Visit 1 PLACE trial) after either two PDT treatments in or two HSML treatments, - Subjects with recurrence of SRF on OCT at the final follow-up visit of the PLACE trial after one PDT or one HSML treatment, will be included in the cross-over study. Of note, for SRF on OCT does not have to involve the fovea for patients to be included in the cross-over study. In the Long-term follow-up study, the following patients will be included: - Subjects who do not show any SRF on OCT at final visit of the PLACE trial will be included. Of note, patients who were not initially included in the long-term follow-up study, because of persistent SRF on OCT, were automatically included in the cross-over study.

Exclusion criteria

Exclusion criteria: For this study no exclusion criteria are applicable.

Design outcomes

Primary

Measure	Time frame
- Absence of subretinal fluid on OCT at the long-term follow up visit, one year after baseline (final visit of the PLACE trial). - Absence of subretinal fluid on OCT at the evaluation visit 6-8 weeks after either first or second cross-over treatment as compared to either baseline (baseline = visit (last evaluation) at 7-8 months after first treatment in PLACE trial) or first re-treatment evaluation visit.	—

Measure

Time frame

- Absence of subretinal fluid on OCT at the long-term follow up visit, one year after baseline (final visit of the PLACE trial). - Absence of subretinal fluid on OCT at the evaluation visit 6-8 weeks after either first or second cross-over treatment as compared to either baseline (baseline = visit (last evaluation) at 7-8 months after first treatment in PLACE trial) or first re-treatment evaluation visit.

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Secondary

Measure	Time frame
- Mean change in ETDRS BCVA in the study eye from baseline to final follow-up visit (1 year after baseline). - Mean change in retinal sensitivity on microperimetry in the study eye from baseline to final follow-up visit (1 year after baseline). - Mean change in the NEI VFQ-25 questionnaire from baseline to final follow-up visit (1 year after baseline). - Number of recurrences of CSC within follow-up period.	—

Measure

Time frame

- Mean change in ETDRS BCVA in the study eye from baseline to final follow-up visit (1 year after baseline). - Mean change in retinal sensitivity on microperimetry in the study eye from baseline to final follow-up visit (1 year after baseline). - Mean change in the NEI VFQ-25 questionnaire from baseline to final follow-up visit (1 year after baseline). - Number of recurrences of CSC within follow-up period.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)